Biomet Recalls Hip Joint Components Due to Incorrect GTIN Labeling
Biomet is recalling 1,315 hip joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is limited to incorrect GTIN labeling codes, which is a documentation or packaging-only problem.
Plain-English summary
Biomet, Inc. is recalling 1,315 units of Cobalt-Chrome Femoral Components, which are hip joint replacement parts. The recall is being conducted because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
The affected products include femoral stems, femoral heads, acetabular shells, and acetabular liners. The specific part numbers involved are 163667, 163668, 163669, 163670, and 163674. The use-by date for these components is March 18, 2025.
The products were distributed worldwide, including in the United States and various international locations. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this labeling recall.
The recalled product
- 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…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 1,315
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 4 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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