{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196483", "product_res_number": "Z-0197-2023", "event_date_initiated": "2022-09-30", "event_date_posted": "2022-11-08", "recall_status": "Open, Classified", "res_event_number": "91005", "product_code": "HTS", "product_description": "Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery).\nCatalog#: 376780", "code_info": "UDI# 00886158001249\nLOT#'s: 6034831,6039837", "firm_fei_number": "1211998", "recalling_firm": "Beaver Visitec International, Inc.", "address_1": "500 Totten Pond Rd 10 City Point", "city": "Waltham", "state": "MA", "postal_code": "02451-1916", "additional_info_contact": "SAME\n781-906-7950", "reason_for_recall": "Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery", "root_cause_description": "Under Investigation by firm", "action": "Beaver Visitec informed by a written letter notification coupled with an email on 9/30/22.\nLetter states reason for recall, health risk and action to take:\n1. Immediately examine your inventory and quarantine product from these lots that are subject to recall. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged\nto use a copy of this recall notification letter when contacting your customers.\n2. Complete the enclosed Business Response Form (BRF) and indicate whether or not you have affected product to return. Please return the business response form to beavervisitec2765@sedgwick.com even if you no longer have product on hand.\n\n3. Please enter the following information on the enclosed BRF: company name, lot number(s) and quantity(ies) of device(s) that are being returned.\n4. If you have any questions regarding this Field Action, please contact BVI Sedgwick at 866-382-8606 or beavervisitec2765@sedgwick.com.\nIf you have affected product, please return product with copy of BRF to:\nReturn your product to SEDGWICK using the enclosed UPS pre-paid return label:\nAttn: Event 2765 Sedgwick\n2670 Executive Drive, Suite A\nIndianapolis, IN 46241\nA credit will be provided to consignees who have replied with confirmation of receiving affected product. Please direct any questions regarding credit to our customer service department by email ClaimsUS@bvimedical.com and include in the subject line: Master Case PIR 00371817.", "product_quantity": "150 units US; 1116 units OUS", "distribution_pattern": "FL, GA, IN, LA, MA, ME, VA\nForeign: France, Japan, Netherlands, Switzerland, United Kingdom", "openfda": { "device_name": "Knife, Orthopedic", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1", "registration_number": [ "3003120897", "3011024991", "3039103971", "3007327603", "1416666", "1220477", "9614986", "3013421458", "1421879", "3018094310", "2031917", "3010455030", "3012130008", "8043971", "8044098", "9610612", "9611278", "3005528784", "3030514683", "9613910", "2936485", "3021948057", "3010303097", "1526439", "3005440795", "3023657851", "9612277", "3005641619", "1828464", "1824199", "8040278", "9710524", "3003407244", "3009790163", "9611102", "9613083", "8010769", "1221934", "3010536692", "3007887711", "9611274", "8040179", "2916714", "9680518", "9611283", "3008837339", "9680059", "3003435550", "3021519357", "8010733", "9612075", "3010097171", "1030489", "1417592", "1836161", "3003418325", "3005809810", "1058584", "3004608878", "1211998", "1526534", "8040233", "3013497507", "3015167917", "3006639700", "3004464325", "3009189869", "3013846070", "3009756153", "3010041511", "9680519", "3014334038", "3015176311", "3042508254", "1822565", "3015259876", "1720747", "1421101", "1017294", "3005061536", "8010704", "1923569", "3027262786", "2529846", "8030607", "3018821071", "2027467", "8010379", "3005751028", "8010099", "3032391", "3009702671", "3015895045", "9680718", "9613926", "9611112", "3008936260", "1319660", "3005067367", "3011137372", "3019878714", "9612278", "8043441", "3003696170", "3013466775", "3009513193", "3033536312", "8043816", "3005273623", "3008770252", "2249529", "2431166", "1218017", "3008114965", "3008076203", "3004774118", "8010155", "1222773" ], "fei_number": [ "1000219637", "3003120897", "3011024991", "3039103971", "3007327603", "1416666", "1220477", "3013421458", "3005734757", "3018094310", "3010455030", "3012130008", "3005304066", "1000220733", "3001417518", "3005528784", "3030514683", "2936485", "3021948057", "3010303097", "1526439", "3005440795", "3005747797", "3004028763", "3023657851", "3003944071", "3005641619", "1828464", "5870", "1824199", "3003407244", "3009790163", "3003424264", "3000280067", "1000136191", "1221934", "1000120768", "3010536692", "3007887711", "2523865", "2916714", "3002807328", "3008837339", "3003435550", "3021519357", "3004574120", "3002806862", "3010097171", "3007714917", "3008782585", "3002929183", "1417592", "3003418325", "3005809810", "3003914946", "3004608878", "3002750084", "1211998", "1000272060", "1526534", "3002299608", "3002806452", "3013497507", "3015167917", "3006639700", "3004464325", "3009189869", "3003499455", "3002809480", "3013846070", "3002808001", "3009756153", "7282", "3010041511", "1000136478", "3014334038", "3002631673", "3002808360", "3015176311", "3042508254", "3015259876", "3546", "1720747", "3002806315", "1421101", "1017294", "3005061536", "1923569", "3002786339", "3027262786", "3002808043", "3018821071", "2027467", "3005751028", "3009702671", "3015895045", "3002808264", "3008936260", "3019878714", "3004216008", "3003696170", "3002806816", "1000115048", "1000402972", "3013466775", "3009513193", "1000199976", "3033536312", "3008599177", "3002807754", "3005273623", "3008770252", "1000477302", "1218017", "3008114965", "4476", "3008076203", "3006509795" ], "k_number": [ "K873714", "K873712", "K873713", "K933921", "K930507", "K882525", "K873711", "K771851", "K842820" ] } } ] }