Home / Recalls / Biomet, Inc. / Z-1756-2015

Z-1756-2015 Class III Terminated

Recalled by Biomet, Inc. — Warsaw, IN

FDA device recall Z-1756-2015 was initiated by Biomet, Inc. on Apr 16, 2015 and is designated Class III. Reason for recall: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. The recall status is terminated (terminated May 16, 2016). Affected quantity: 1315.

Recall Details

Product Type: Devices
Report Date: Jun 17, 2015
Initiation Date: Apr 16, 2015
Termination Date: May 16, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1315

Product Description

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.

Reason for Recall

Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

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.

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1756-2015
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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