Skip to content
Recall Observatory FDA recall evidence

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

April 16, 2015

Class III

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

    reason.labeling_packaging · v1.0.0

    labeling contains incorrect