{ "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": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Mercedita", "state": "PR", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "72900", "recalling_firm": "Zimmer Manufacturing B.V.", "address_1": "Turpeaux Industrial Park Rd 1 km 123.4", "address_2": "", "postal_code": "00715", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution", "recall_number": "Z-1100-2016", "product_description": "Product 2 consists of all products product code LPH, and same usage: 801802202\t12/14 COCR FEMORAL HEAD 2 801802220\t12/14 COCR FEMORAL HEAD 2 801802230\t12/14 COCR FEMORAL HEAD 2 801802601\t12/14 COCR FEMORAL HEAD 2 801802602\t12/14 COCR FEMORAL HEAD 2 801802603\t12/14 COCR FEMORAL HEAD 2 801802604\t12/14 COCR FEMORAL HEAD 2 801802605\t12/14 COCR FEMORAL HEAD 2 801802801\t12/14 COCR FEMORAL HEAD 2 801802802\t12/14 COCR FEMORAL HEAD 2 801802803\t12/14 COCR FEMORAL HEAD 2 801802805\t12/14 COCR FEMORAL HEAD 2 801802814\t12/14 COCR FEMORAL HEAD 2 801803201\t12/14 COCR FEMORAL HEAD 3 801803202\t12/14 COCR FEMORAL HEAD 3 801803203\t12/14 COCR FEMORAL HEAD 3 801803205\t12/14 COCR FEMORAL HEAD 3 801803214\t12/14 COCR FEMORAL HEAD 3 801803601\t12/14 COCR FEMORAL HEAD 3 801803602\t12/14 COCR FEMORAL HEAD 3 801803603\t12/14 COCR FEMORAL HEAD 3 801803604\t12/14 COCR FEMORAL HEAD 3 801803605\t12/14 COCR FEMORAL HEAD 3 801804001\t12/14 COCR FEMORAL HEAD 4 801804002\t12/14 COCR FEMORAL HEAD 4 801804003\t12/14 COCR FEMORAL HEAD 4 801804004\t12/14 COCR FEMORAL HEAD 4 902602100\t6 DEGREE COCR FEM HEAD 22 32902603935\tFEM HD 26MMDIA SHT NK+ 32902603800\tFEMORAL HEAD +0.5 X 22 MM 32902604810\tFEMORAL HEAD +3.5 X 22 MM 32902604845\tFEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty", "product_quantity": "35,032", "reason_for_recall": "As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.", "recall_initiation_date": "20160111", "center_classification_date": "20160312", "termination_date": "20170413", "report_date": "20160323", "code_info": "lot no. 61982251 61982253 62192505 62235729 62235730 62240303 62240304 62240305 62256057 62262795 62262796 62266503 62266504 62268529 62268530 62268533 62291950 62291952 62291954 62291955 62291956 62309178 62309180 62309182 62309184 62340128 62340129 62340130 62343407 62360082 62360083 62360103 62383105 62383106 62383107 62384211 62384212 61674847 62192500 62235731 62240306 62256051 62256052 62268531 62291959 62291960 62314454 62314455 62340132 62383102 62383103 62383104 62400488 61659979 61674849 62005410 62054842 62192496 62192498 62240307 62256054 62256055 62268532 62291957 62291958 62309177 62314456 62340133 62384213 62395856 62395857 62395858 62400490 61664630 62203617 62384215 62268528 62384214 61634943 62203620 62384216 62400542 62203620N 62384217 62400492 61670802 61683632 00370435N 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