{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "185863", "product_res_number": "Z-1349-2021", "event_date_initiated": "2021-02-12", "event_date_posted": "2021-04-05", "recall_status": "Open, Classified", "res_event_number": "87353", "product_code": "HSB", "k_numbers": [ "K101997", "K151131" ], "product_description": "NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System\n\nEnd Cap for PRECICE Intramedullary Limb Lengthening System Implant;\nPackaged End Cap 8.5/10.7mm, +0mm;\nPackaged End Cap 8.5/10.7mm, +5mm;\nPackaged End Cap 8.5/10.7mm, +10mm;\nPackaged End Cap 8.5/10.7mm, +15mm;\nPackaged End Cap 8.5/10.7mm, +20mm;\nPackaged End Cap 12.5mm, +0mm;\nPackaged End Cap 12.5mm, +5mm;\nPackaged End Cap 12.5mm, +10mm;\nPackaged End Cap 12.5mm, +15mm;\nPackaged End Cap 12.5mm, +20mm;\n3.5 mm Locking Screw, 20 mm Length;\n3.5 mm Locking Screw 25 mm Length;\n3.5 mm Locking Screw 30 mm Length;\n3.5 mm Locking Screw 35 mm Length;\n3.5 mm Locking Screw 40 mm Length;\n3.5 mm Locking Screw 45 mm Length;\n3.5 mm Locking Screw 50 mm Length;\n3.5 mm Locking Screw 55 mm Length;\n3.5 mm Locking Screw 60 mm Length;\nLocking Screw, 3.5x65mm;\nLocking Screw, 3.5x70mm;\nLocking Screw, 3.5x75mm;\n4.0 mm Locking Screw 20 mm Length;\n4.0 mm Locking Screw 25 mm Length;\n4.0 mm Locking Screw 30 mm Length;\n4.0 mm Locking Screw 35 mm Length;\n4.0 mm Locking Screw 40 mm Length;\n4.0 mm Locking Screw 45 mm Length;\n4.0 mm Locking Screw 50 mm Length;\n4.0 mm Locking Screw 55 mm Length;\n4.0 mm Locking Screw 60 mm Length;\n5.0 mm Locking Screw 20 mm Length;\n5.0 mm Locking Screw 25 mm Length;\n5.0 mm Locking Screw 30 mm Length;\n5.0 mm Locking Screw 35 mm Length;\n5.0 mm Locking Screw 40 mm Length;\n5.0 mm Locking Screw 45 mm Length;\n5.0 mm Locking Screw 50 mm Length;\n5.0 mm Locking Screw 55 mm Length;\n5.0 mm Locking Screw 60 mm Length;\n5.0 mm Locking Screw 65 mm Length;\n5.0 mm Locking Screw 70 mm Length;\n5.0 mm Locking Screw 75 mm Length;\n4.0 mm Locking Screw 20 mm Length;\n4.0 mm Locking Screw 25 mm Length;\n4.0 mm Locking Screw 30 mm Length;\n4.0 mm Locking Screw 35 mm Length;\n4.0 mm Locking Screw 40 mm Length;\n4.0 mm Locking Screw 45 mm Length;\n4.0 mm Locking Screw 50 mm Length;\n4.0 mm Locking Screw 55 mm Length;\n4.0 mm Locking Screw 60 mm Length;\n4.0 mm X 65 mm Locking Screw, Peg;\n4.0 mm X 70 mm Locking Screw, Peg; \n4.0 mm X 75 mm Locking Screw, Peg;\n4.0 mm X 80 mm Locking Screw, Peg;\n4.0 mm X 85 mm Locking Screw, Peg; \n4.0 mm X 90 mm Locking Screw, Peg;\n4.0 mm X 95 mm Locking Screw, Peg; \n4.0 mm X 100 mm Locking Screw, Peg; \n5.0 mm Locking Screw 20 mm Length;\n5.0 mm Locking Screw 25 mm Length;\n5.0 mm Locking Screw 30 mm Length;\n5.0 mm Locking Screw 35 mm Length;\n5.0 mm Locking Screw 40 mm Length;\n5.0 mm Locking Screw 45 mm Length;\n5.0 mm Locking Screw 50 mm Length;\n5.0 mm Locking Screw 55 mm Length;\n5.0 mm Locking Screw 60 mm Length;\n5.0 mm Locking Screw 65 mm Length;\n5.0 mm Locking Screw 70 mm Length;\n5.0 mm Locking Screw 75 mm Length;\n5.0 mm X 80 mm Locking Screw, Peg;\n5.0 mm X 85 mm Locking Screw, Peg; \n5.0 mm X 90 mm Locking Screw, Peg;\n5.0 mm X 95 mm Locking Screw, Peg;\n5.0 mm X 100 mm Locking Screw, Peg; \nOrthopedic intramedullary limb lengthening rod, retrograde femur 10 degree, 10.7 mm diameter, 170 mm length;\nOrthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 160 mm length;\nOrthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 10.7 mm diameter, 170 mm length;\nOrthopedic intramedullary limb lengthening rod, universal femur, 10.7 mm diameter, 170 mm length;\nOrthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 215 mm length;\nOrthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 230 mm length;\nOrthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 215 mm length;\nOrthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 230 mm length;\nOrthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 195 mm length;\nOrthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 215 mm length;\nOrthopedic intramedullary limb lengthening", "code_info": "All Lots manufactured between April 2015 to February 2021.  PRECICE Intramedullary Limb Lengthening (IMLL) Product Codes:  End caps: CPA1-000; CPA2-000; CPA2-005; CPA2-010; CPA2-015; CPA2-020; CPA3-000; CPA3-005; CPA3-010; CPA3-015; CPA3-020;  Locking screws:  LSB3-020; LSB3-025; LSB3-030; LSB3-035; LSB3-040; LSB3-045; LSB3-050; LSB3-055; LSB3-060; LSB3-065; LSB3-070; LSB3-075; LSB4-020; LSB4-025; LSB4-030; LSB4-035; LSB4-040; LSB4-045; LSB4-050; LSB4-055; LSB4-060; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC4-020; LSC4-025; LSC4-030; LSC4-035; LSC4-040; LSC4-045; LSC4-050; LSC4-055; LSC4-060; LSC4-065; LSC4-070; LSC4-075; LSC4-080; LSC4-085; LSC4-090; LSC4-095; LSC4-100; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100;   Limb lengthening intramedullary rods 10.7 mm diameter:  P10.7-30H170; P10.7-30J160; P10.7-30K170; P10.7-30U170; P10.7-50A215; P10.7-50A230; P10.7-50B215; P10.7-50B230; P10.7-50C195; P10.7-50C215; P10.7-50C230; P10.7-50D215; P10.7-50D230; P10.7-50E215; P10.7-50E230; P10.7-50H190; P10.7-50J180; P10.7-50K190; P10.7-50M175; P10.7-50N160; P10.7-50P175; P10.7-50Q155; P10.7-50U190; P10.7-50V215; P10.7-50V230; P10.7-50X215; P10.7-50X230; P10.7-80A245; P10.7-80A275; P10.7-80A305; P10.7-80A335; P10.7-80A365; P10.7-80B245; P10.7-80B275; P10.7-80B305; P10.7-80B335; P10.7-80B365; P10.7-80C245; P10.7-80C275; P10.7-80C305; P10.7-80C335; P10.7-80C365; P10.7-80D245; P10.7-80D275; P10.7-80D305; P10.7-80D335; P10.7-80D365; P10.7-80E245; P10.7-80E275; P10.7-80E305; P10.7-80E335; P10.7-80E365; P10.7-80V245; P10.7-80V275; P10.7-80V305; P10.7-80V335; P10.7-80V365; P10.7-80X245; P10.7-80X275; P10.7-80X305; P10.7-80X335; P10.7-80X365;   Limb lengthening intramedullary rods 12.5 mm diameter:  P12.5-30H170; P12.5-30J160; P12.5-30K170; P12.5-30U170; P12.5-50A215; P12.5-50A230; P12.5-50B215; P12.5-50B230; P12.5-50C195; P12.5-50C215; P12.5-50C230; P12.5-50D215; P12.5-50D230; P12.5-50E215; P12.5-50E230; P12.5-50H190; P12.5-50J180; P12.5-50K190; P12.5-50U190; P12.5-50V215; P12.5-50V230; P12.5-50X215; P12.5-50X230; P12.5-80A245; P12.5-80A275; P12.5-80A305; P12.5-80A335; P12.5-80A365; P12.5-80B245; P12.5-80B275; P12.5-80B305; P12.5-80B335; P12.5-80B365; P12.5-80C245; P12.5-80C275; P12.5-80C305; P12.5-80C335; P12.5-80C365; P12.5-80D245; P12.5-80D275; P12.5-80D305; P12.5-80D335; P12.5-80D365; P12.5-80E245; P12.5-80E275; P12.5-80E305; P12.5-80E335; P12.5-80E365; P12.5-80V245; P12.5-80V275; P12.5-80V305; P12.5-80V335; P12.5-80V365; P12.5-80X245; P12.5-80X275; P12.5-80X305; P12.5-80X335; P12.5-80X365;   Limb lengthening intramedullary rods 8.5 mm diameter:  P8.5-30H170; P8.5-30J160; P8.5-30K170; P8.5-30U170; P8.5-50A215; P8.5-50A230; P8.5-50B215; P8.5-50B230; P8.5-50C195; P8.5-50C215; P8.5-50C230; P8.5-50D215; P8.5-50D230; P8.5-50E215; P8.5-50E230; P8.5-50H190; P8.5-50J180; P8.5-50K190; P8.5-50M165; P8.5-50N150 P8.5-50P165; P8.5-50Q155; P8.5-50U190; P8.5-50V215; P8.5-50V230; P8.5-50X215; P8.5-50X230; P8.5-80A245; P8.5-80A275; P8.5-80A305; P8.5-80A335; P8.5-80A365; P8.5-80B245; P8.5-80B275; P8.5-80B305; P8.5-80B335; P8.5-80B365; P8.5-80C245; P8.5-80C275; P8.5-80C305; P8.5-80C335; P8.5-80C365; P8.5-80D245; P8.5-80D275; P8.5-80D305; P8.5-80D335; P8.5-80D365; P8.5-80E245; P8.5-80E275; P8.5-80E305; P8.5-80E335; P8.5-80E365; P8.5-80V245; P8.5-80V275; P8.5-80V305; P8.5-80V335; P8.5-80V365; P8.5-80X245; P8.5-80X275; P8.5-80X305; P8.5-80X335; P8.5-80X365;    Limb lengthening intramedullary rods 10.5 mm diameter:  PR10.5-50A215; PR10.5-50A230; PR10.5-50B215; PR10.5-50B230; PR10.5-50C195; PR10.5-50C215; PR10.5-50C230; PR10.5-50D215; PR10.5-50D230; PR10.5-50E215; PR10.5-50E230; PR10.5-80A245; PR10.5-80A275; PR10.5-80A305; PR10.5-80A335; PR10.5-80A365; PR10.5-80B245; PR10.5-80B275; PR10.5-80B305; PR10.5-80B335; PR10.5-80B365; PR10.5-80C245; PR10.5-80C275; PR10.5-80C305; PR10.5-80C335; PR10.5-80C365; PR10.5-80D245; PR10.5-80D275; PR10.5-80D305; PR10.5-80D335; PR10.5-80D365; PR10.5-80E245; PR10.5-80E275; PR10.5-80E305; PR10.5-80E335; PR10.5-80E365;    Limb lengthening intramedullary rods 11.5 mm diameter:  PR11.5-50A215; PR11.5-50A230; PR11.5-50B215; PR11.5-50B230; PR11.5-50C195; PR11.5-50C215; PR11.5-50C230; PR11.5-50D215; PR11.5-50D230; PR11.5-50E215; PR11.5-50E230; PR11.5-80A245; PR11.5-80A275; PR11.5-80A305; PR11.5-80A335; PR11.5-80A365; PR11.5-80B245; PR11.5-80B275; PR11.5-80B305; PR11.5-80B335; PR11.5-80B365; PR11.5-80C245; PR11.5-80C275; PR11.5-80C305; PR11.5-80C335; PR11.5-80C365; PR11.5-80D245; PR11.5-80D275; PR11.5-80D305; PR11.5-80D335; PR11.5-80D365; PR11.5-80E245; PR11.5-80E275; PR11.5-80E305; PR11.5-80E335; PR11.5-80E365;   Limb lengthening intramedullary rods 12.5 mm diameter:  PR12.5-50A215; PR12.5-50A230; PR12.5-50B215; PR12.5-50B230; PR12.5-50C195; PR12.5-50C215; PR12.5-50C230; PR12.5-50D215; PR12.5-50D230; PR12.5-50E215; PR12.5-50E230; PR12.5-80A245; PR12.5-80A275; PR12.5-80A305; PR12.5-80A335; PR12.5-80A365; PR12.5-80B245; PR12.5-80B275; PR12.5-80B305; PR12.5-80B335; PR12.5-80B365; PR12.5-80C245; PR12.5-80C275; PR12.5-80C305; PR12.5-80C335; PR12.5-80C365; PR12.5-80D245; PR12.5-80D275; PR12.5-80D305; PR12.5-80D335; PR12.5-80D365; PR12.5-80E245; PR12.5-80E275; PR12.5-80E305; PR12.5-80E335; PR12.5-80E365;   Limb lengthening intramedullary rods 9.0 mm diameter:  PR9.0-50A215; PR9.0-50A230; PR9.0-50B215; PR9.0-50B230; PR9.0-50C195; PR9.0-50C215; PR9.0-50C230; PR9.0-50D215; PR9.0-50D230; PR9.0-50E215; PR9.0-50E230; PR9.0-80A245; PR9.0-80A275; PR9.0-80A305; PR9.0-80A335; PR9.0-80A365; PR9.0-80B245; PR9.0-80B275; PR9.0-80B305; PR9.0-80B335; PR9.0-80B365; PR9.0-80C245; PR9.0-80C275; PR9.0-80C305; PR9.0-80C335; PR9.0-80C365; PR9.0-80D245; PR9.0-80D275; PR9.0-80D305; PR9.0-80D335; PR9.0-80D365; PR9.0-80E245; PR9.0-80E275; PR9.0-80E305; PR9.0-80E335; PR9.0-80E365;   Limb lengthening intramedullary rods 9.5 mm diameter:  PR9.5-50A215; PR9.5-50A230; PR9.5-50B215; PR9.5-50B230; PR9.5-50C195; PR9.5-50C215; PR9.5-50C230; PR9.5-50D215; PR9.5-50D230; PR9.5-50E215; PR9.5-50E230; PR9.5-80A245; PR9.5-80A275; PR9.5-80A305; PR9.5-80A335; PR9.5-80A365; PR9.5-80B245; PR9.5-80B275; PR9.5-80B305; PR9.5-80B335; PR9.5-80B365; PR9.5-80C245; PR9.5-80C275; PR9.5-80C305; PR9.5-80C335; PR9.5-80C365; PR9.5-80D245; PR9.5-80D275; PR9.5-80D305; PR9.5-80D335; PR9.5-80D365; PR9.5-80E245; PR9.5-80E275; PR9.5-80E305; PR9.5-80E335; PR9.5-80E365;   Trauma intramedullary rods 10.7 mm diameter:  T10.7-50A205; T10.7-50A225; T10.7-50A240; T10.7-50B205; T10.7-50B225; T10.7-50B240; T10.7-50C205; T10.7-50C225; T10.7-50C240; T10.7-50D205; T10.7-50D225; T10.7-50D240; T10.7-50E205; T10.7-50E225; T10.7-50E240; T10.7-80A255; T10.7-80A285; T10.7-80A315; T10.7-80A345; T10.7-80A375; T10.7-80B255; T10.7-80B285; T10.7-80B315; T10.7-80B345; T10.7-80B375; T10.7-80C255; T10.7-80C285; T10.7-80C315; T10.7-80C345; T10.7-80C375; T10.7-80D255; T10.7-80D285; T10.7-80D315; T10.7-80D345; T10.7-80D375; T10.7-80E255; T10.7-80E285; T10.7-80E315; T10.7-80E345; T10.7-80E375;   Trauma intramedullary rods 12.5 mm diameter:  T12.5-50A205; T12.5-50A225; T12.5-50A240; T12.5-50B205; T12.5-50B225; T12.5-50B240; T12.5-50C205; T12.5-50C225; T12.5-50C240; T12.5-50D205; T12.5-50D225; T12.5-50D240; T12.5-50E205; T12.5-50E225; T12.5-50E240; T12.5-80A255; T12.5-80A285; T12.5-80A315; T12.5-80A345; T12.5-80A375; T12.5-80B255; T12.5-80B285; T12.5-80B315; T12.5-80B345; T12.5-80B375; T12.5-80C255; T12.5-80C285; T12.5-80C315; T12.5-80C345; T12.5-80C375; T12.5-80D255; T12.5-80D285; T12.5-80D315; T12.5-80D345; T12.5-80D375; T12.5-80E255; T12.5-80E285; T12.5-80E315; T12.5-80E345; T12.5-80E375;   Trauma intramedullary rods 8.5 mm diameter:  T8.5-50A205; T8.5-50A225; T8.5-50A240; T8.5-50B205; T8.5-50B225; T8.5-50B240; T8.5-50C205; T8.5-50C225; T8.5-50C240; T8.5-50D205; T8.5-50D225; T8.5-50D240; T8.5-50E205; T8.5-50E225; T8.5-50E240; T8.5-80A255; T8.5-80A285; T8.5-80A315; T8.5-80A345; T8.5-80A375; T8.5-80B255; T8.5-80B285; T8.5-80B315; T8.5-80B345; T8.5-80B375; T8.5-80C255; T8.5-80C285; T8.5-80C315; T8.5-80C345; T8.5-80C375; T8.5-80D255; T8.5-80D285; T8.5-80D315; T8.5-80D345; T8.5-80D375; T8.5-80E255; T8.5-80E285; T8.5-80E315; T8.5-80E345; T8.5-80E375;  Locking screws:  TSA4.5-020; TSA4.5-025; TSA4.5-030; TSA4.5-035; TSA4.5-040; TSA4.5-045; TSA4.5-050; TSA4.5-055; TSA4.5-060; TSA4.5-065; TSA4.5-070; TSA4.5-075; TSA4-020; TSA4-022.5; TSA4-025; TSA4-027.5; TSA4-030; TSA4-032.5; TSA4-035; TSA4-037.5; TSA4-040; TSA4-042.5; TSA4-045; TSA4-047.5; TSA4-050; TSA4-055; TSA4-060; TSA4-065; TSA4-070; TSA4-075; TSA4-080; TSA4-085; TSA4-090; TSA4-095; TSA4-100; TSA4-100; TSA5-020; TSA5-020; TSA5-022.5; TSA5-022.5; TSA5-025; TSA5-025; TSA5-027.5; TSA5-027.5; TSA5-030; TSA5-030; TSA5-032.5; TSA5-032.5; TSA5-035; TSA5-035; TSA5-037.5; TSA5-037.5; TSA5-040; TSA5-040; TSA5-042.5; TSA5-042.5; TSA5-045; TSA5-045; TSA5-047.5; TSA5-047.5; TSA5-050; TSA5-050; TSA5-052.5; TSA5-055; TSA5-055; TSA5-057.5; TSA5-060; TSA5-060; TSA5-062.5; TSA5-065; TSA5-065; TSA5-067.5; TSA5-070; TSA5-070; TSA5-072.5; TSA5-075; TSA5-075; TSA5-080; TSA5-080; TSA5-085; TSA5-085; TSA5-090; TSA5-090; TSA5-095; TSA5-095; TSA5-100; TSA5-100; TSA5-105; TSA5-105; TSA5-110; TSA5-110;  GTIN Numbers: 00812258020002; 00887517001139; 00887517001146; 00887517001153; 00887517001160; 00887517001177; 00887517001184; 00887517001191; 00887517001207; 00887517001214; 00887517001221; 00812258021337; 00812258021344; 00812258021351; 00812258021368; 00812258021375; 00812258021382; 00812258021399; 00812258021405; 00812258021412; 00887517936233; 00887517936240; 00887517936257; 00856719002763; 00856719002770; 00856719002787; 00856719002794; 00856719002800; 00856719002817; 00856719002824; 00856719002831; 00856719002848; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992; 00812258021429; 00812258021436; 00812258021443; 00812258021450; 00812258021467; 00812258021474; 00812258021481; 00812258021498; 00812258021504; 00887517000958; 00887517000965; 00887517000972; 00887517000989; 00887517000996; 00887517001009; 00887517001016; 00887517001023; 00812258021511; 00812258021528; 00812258021535; 00812258021542; 00812258021559; 00812258021566; 00812258021573; 00812258021580; 00812258021597; 00812258021603; 00812258021610; 00812258021627; 00887517001030; 00887517001047; 00887517001054; 00887517001061; 00887517001078; 00812258026073; 00812258026134; 00812258026196; 00812258026257; 00812258020057; 00812258020064; 00812258020231; 00812258020248; 00812258020422; 00812258020439; 00812258020446; 00812258020620; 00812258020637; 00812258020804; 00812258020811; 00812258026080; 00812258026141; 00812258026202; 00812258028244; 00812258028268; 00812258028282; 00812258028220; 00812258026264; 00887517934819; 00887517934826; 00887517934833; 00887517934840; 00812258020071; 00812258020088; 00812258020095; 00812258020101; 00812258020118; 00812258020255; 00812258020262; 00812258020279; 00812258020286; 00812258020293; 00812258020453; 00812258020460; 00812258020477; 00812258020484; 00812258020491; 00812258020644; 00812258020651; 00812258020668; 00812258020675; 00812258020682; 00812258020828; 00812258020835; 00812258020842; 00812258020859; 00812258020866; 00887517934857; 00887517934864; 00887517934871; 00887517934888; 00887517934895; 00887517935502; 00887517935519; 00887517935526; 00887517935533; 00887517935540; 00812258026097; 00812258026158; 00812258026219; 00812258026271; 00812258020125; 00812258020132; 00812258020309; 00812258020316; 00812258020507; 00812258020514; 00812258020521; 00812258020699; 00812258020705; 00812258020873; 00812258020880; 00812258026103; 00812258026165; 00812258026226; 00812258026288; 00887517935557; 00887517935564; 00887517935571; 00887517935588; 00812258020149; 00812258020156; 00812258020163; 00812258020170; 00812258020187; 00812258020323; 00812258020330; 00812258020347; 00812258020354; 00812258020361; 00812258020538; 00812258020545; 00812258020552; 00812258020569; 00812258020576; 00812258020712; 00812258020729; 00812258020736; 00812258020743; 00812258020750; 00812258020897; 00812258020903; 00812258020910; 00812258020927; 00812258020934; 00887517935595; 00887517935601; 00887517935618; 00887517935625; 00887517935632; 00887517935649; 00887517935656; 00887517935663; 00887517935670; 00887517935687; 00812258026059; 00812258026110; 00812258026172; 00812258026233; 00812258020019; 00812258020026; 00812258020194; 00812258020200; 00812258020378; 00812258020385; 00812258020392; 00812258020583; 00812258020590; 00812258020767; 00812258020774; 00812258026066; 00812258026127; 00812258026189; 00812258028237; 00812258028251; 00812258028275; 00812258028213; 00812258026240; 00887517935694; 00887517935700; 00887517935717; 00887517935724; 00812258020033; 00812258020040; 00812258022358; 00812258022365; 00812258022372; 00812258020217; 00812258020224; 00812258022389; 00812258022396; 00812258022402; 00812258020408; 00812258020415; 00812258022419; 00812258022426; 00812258022433; 00812258020606; 00812258020613; 00812258022440; 00812258022457; 00812258022464; 00812258020781; 00812258020798; 00812258022471; 00812258022488; 00812258022495; 00887517935731; 00887517935748; 00887517935755; 00887517935762; 00887517935779; 00887517935786; 00887517935793; 00887517935809; 00887517935816; 00887517935823; 00812258025359; 00812258025366; 00812258024253; 00812258024260; 00812258024956; 00812258024963; 00812258024970; 00812258024604; 00812258024611; 00812258025700; 00812258025717; 00812258025373; 00812258025380; 00812258025397; 00812258025403; 00812258025410; 00812258024277; 00812258024284; 00812258024291; 00812258024307; 00812258024314; 00812258024987; 00812258024994; 00812258025007; 00812258025014; 00812258025021; 00812258024628; 00812258024635; 00812258024642; 00812258024659; 00812258024666; 00812258025724; 00812258025731; 00812258025748; 00812258025755; 00812258025762; 00812258025427; 00812258025434; 00812258024321; 00812258024338; 00812258025038; 00812258025045; 00812258025052; 00812258024673; 00812258024680; 00812258025779; 00812258025786; 00812258025441; 00812258025458; 00812258025465; 00812258025472; 00812258025489;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7000392; 00812258027872; 00812258027889; 00887517000408; 00812258027896; 00812258027902; 00887517000415; 00812258027919; 00812258027926; 00887517000422; 00812258027933; 00812258027940; 00887517000439; 00812258027957; 00887517000446; 00812258027964; 00887517000453; 00812258027971; 00887517000460; 00812258027988; 00887517000477; 00812258027995; 00887517000484; 00812258028008; 00812258028008; 00812258028015; 00812258028015;", "firm_fei_number": "3006179046", "recalling_firm": "Nuvasive Specialized Orthopedics Inc", "address_1": "101 Enterprise Ste 100 101 Enterprise", "address_2": "Ste 100", "city": "Aliso Viejo", "state": "CA", "postal_code": "92656-2604", "reason_for_recall": "Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.", "root_cause_description": "Device Design", "action": "On 02/11/2021, the firm started emailing an \"URGENT FIELD SAFETY NOTICE\" Notification to customers informing them that due to not having the full complement of biological assessments, the devices are not indicated for use in individuals under the age of 18 years old.\n\nCustomers are informed to:\n-An Recalling Firm representative will be contacting your office or you to help with any questions or concerns.\n-Review, complete, sign and return the attached Consignee Confirmation Form\naccompanying this notification in accordance with the directions on the form.\n-If a patient has been previously implanted with a listed device and was under the age of 18, consultation may be warranted, at the discretion of the provider.\n-If a patient has been previously implanted with a listed device and is pregnant, becomes pregnant, or intends to become pregnant, consultation may be warranted, at the discretion of the provider.\n-Forward this notice to anyone in your facility that needs to be informed.\n-Direct any additional manufacturer inquiries to FSNprecice@nuvasive.com\n-Report to NSO any adverse effect or product complaints related to the use of these devices to FSNprecice@nuvasive.com, whether or not those adverse effects are related to this FSN.\nAs a reminder, the following guidelines according to the Instructions for Use, including, but not limited to:\n-The IFU should be consulted on an ongoing basis before and throughout patient\ntreatment with Precice products.\n-These Precice family of devices are contraindicated in patients in which the Precice devices would cross joint spaces or open epiphyseal growth plates.\n-These Precice family of devices are contraindicated in patients unwilling or incapable of following postoperative care instructions.\n-Precice System devices should be removed after an implantation period of no more than one year.\n-Once the physician determines that the Precice/Short/Freedom/Unyte System has achieved its intended use and is no longer requir", "product_quantity": "10,657 units", "distribution_pattern": "Worldwide distribution, including U.S. Nationwide.", "openfda": { "k_number": [ "K952739", "K182307", "K141228", "K133081", "K010901", "K200869", "K992063", "K123569", "K092110", "K092646", "K102413", "K011857", "K043404", "K150471", "K250559", "K160545", "K920666", "K033329", "K162927", "K233696", "K163368", "K173811", "K003797", "K972813", "K870040", "K142599", "K130051", "K132005", "K170972", "K022225", 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