Biomet Hip Stem Recall for Incorrect PMMA Labeling
Biomet is recalling 21 hip stem implants because the label incorrectly lists PMMA as a material, though the product does not contain it.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding material composition without reported injuries or illnesses, fitting the 'Moderate' severity criteria.
Plain-English summary
Biomet, Inc. is recalling 21 units of the Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo) in sizes 9mm, 11mm, 13mm, 15mm, and 17mm. The recall is due to a labeling error where Polymethylmethacrylate (PMMA) is listed as a material on the label, but the product does not actually contain PMMA.
The affected devices were distributed worldwide, including nationwide in the United States (specifically IA, UT, MN, PA, MO, OK, IL, OH, and WA), Canada, and the Netherlands. Specific lot numbers and part numbers are identified in the recall documentation.
This is a Class II recall. Consumers and healthcare providers should contact Biomet, Inc. for further information regarding the affected lots and part numbers.
The recalled product
- Product
- Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 21
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 (16)
- Part #11-162709 9mm Lots: 329750
- 404380
- 487400
- 767120
- 951680 Part # 11-162711 11mm Lots: 329760
- 505030
- 505050 Part # 11-162713 13mm Lots: 837750
- 977460 Part # 11-162715 15mm 772410
- 837780
- 897070
- 951810 Part # 11-162717 17mm Lots: 311410
- 410500
- 535530
- 712800
- 728080
- 829580
Distribution
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