Biomet, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1756-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: April 16, 2015

Date Posted: June 17, 2015

Recall Number: Z-1756-2015

Event ID: 71171

Reason for Recall:

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

Status: Terminated

Product Quantity: 1315

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.

Voluntary or Mandated:

Voluntary: Firm initiated