Data Foundry

Medical device recalls 2015

MCK Maximum Congruent Knee System — Class III medical device recall Z-1756-2015

Terminated recall by Biomet, Inc., reported 2015-06-17, distributed nationwide. Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN

Recall numberZ-1756-2015
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBiomet, Inc., Warsaw, IN, United States
Recall initiated2015-04-16
Classified2015-06-10
Reported by FDA2015-06-17
Terminated2016-05-16
DistributedNationwide (US)
Countries outside the USAR, AU, CA, CL, CN, JP, KR, MX, NZ, TH, TT
Quantity1,315
Reason classeslabeling
Lot numbers023580, 035650, 035690, 065500, 066850, 066900, 066910, 066930, 066940, 066950, 066960, 066970, 066990, 067010, 077970, 078000, 078020, 078030, 104230, 104240, 104580, 104590, 104600, 104620, 104630, 104640, 104650, 104660, 114930, 125820, 125830, 125840, 125850, 125860, 129180, 183220, 183230, 183240, 183250, 183260 and 39 more
Model numbers141314
Expiration dates2025-03-13

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1756-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.