Zimmer Manufacturing Recalls Sterile Femoral Heads Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling specific sterile femoral heads used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is related to packaging calibration data rather than a direct biological or mechanical failure with reported harm.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific sterile femoral heads used in total or hemi hip arthroplasty. The recall involves product code LPHand, specifically item numbers 32902603800, 32902604810, and 32902604845. These products were distributed nationwide in the United States.
The recall is being conducted because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile. Specific lot numbers are listed in the official recall documentation.
Healthcare providers and facilities should stop using the affected products and contact Zimmer Manufacturing B.V. for further instructions on the recall process.
The recalled product
- Product
- Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty
- Manufacturer
- Zimmer Manufacturing B.V.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. 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.
See all 72 products in this recall →Related recalls
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