Device product
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
Z-1756-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 71171
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1315
- Official record key
device-enforcement:Z-1756-2015
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: 141314; 141316; 141318; 141320; Use-by 2025-03-13; Lot Numbers: 035650; 035690; 065500; 066850; 066900; 066910; 066930; 066940; 066950; 066960; 066970; 066990; 067010; 104580; 104590; 104600; 104620; 104630; 104640; 104650; 104660; 125820; 125830; 125840; 129180; 183220; 183230; 183240; 183250; 183260; 183270; 183280; 183290; 183300; 183310; 183320; 257770; 257780; 257790; 257810; 257850; 257860; 257870; 257880; 299730; 299750; 299760; 299780; 299800; 299810; 299820; 842220; 951620; 954160; 997470; 023580; 077970; 125850; 251680; 335490; 997510; 997520; 997530; 997540; 078000; 078020; 104230; 125860; 251710; 335510; 997550; 997560; 997570; 078030; 104240; 114930; 333940; 529710; 997590
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