Zimmer Distal Femoral Components Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling specific distal femoral components used in hip arthroplasty due to insufficient sealer calibration data.
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 the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific distal femoral components used in total or hemi hip arthroplasty. The affected products are sterile and were packaged in the firm's Building II between August 2010 and April 2013.
The recall is being conducted because of insufficient sealer calibration data for the packaging process during that period. The affected items include various distal medial femoral cones and distal posterior/lateral components under product code JWH.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions regarding the affected lots. The recall covers products distributed nationwide in the United States.
The recalled product
- Product
- Product 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL…
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
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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