Device product
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Z-1757-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 71171
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1315
- Official record key
device-enforcement:Z-1757-2015
Official wording
Reason: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Code information: Part Numbers: 163667; 163668; 163669; 163670; 163674; Use-by 2025-03-18; Lot Numbers: 331620; 331650; 453080; 453090; 453110; 453120; 489140; 453180; 471380; 471410; 044600; 332720; 375590; 375620; 375630; 375640; 375650; 465840; 466050; 470060; 471430; 471440; 471450; 375660; 375670; 375700; 453220
Distribution pattern: Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.
Derived failure modes
-
Labeling or packaging
labeling contains incorrect