Zimmer Manufacturing Recalls Sterile Femoral Hip Implant Components
Zimmer Manufacturing B.V. is recalling specific sterile femoral hip implant components 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile implant) where the hazard is theoretical (insufficient calibration data) and no injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific sterile femoral hip implant components intended for use in total or hemi hip arthroplasty. The recall covers products under product code JDI, specifically item numbers 32902605000 (Femoral HD 28mm Medium), 32902604000 (Femoral HD 28mm Short), and 32902604035 (Femoral HD 28mm Sht+ 3.5m).
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. The recall is classified as Class II by the FDA.
The affected lots are 62185968, 62273370, 62339644, 62162469, 62279774, 62279774N, 62221051, 62279775, and 62279775N. The products were distributed nationwide in the United States. Healthcare providers and patients should contact the manufacturer for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M 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.
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