Zimmer Ion Implanted Femoral Stems Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 17 ion implanted femoral stems used in hip arthroplasty due to insufficient sealer calibration data affecting sterility.
What this means for you
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 involves a risk-of-harm product (sterility failure in an implant) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 17 units of ion implanted femoral stems (product code JDI) used for total or hemi hip arthroplasty. The affected items include specific sizes and configurations (22mm LO, 26mm ME, 26mm SH) distributed nationwide in the United States.
The recall was initiated because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. This issue raises concerns regarding the sterility of the affected medical devices. The source text does not report any illnesses or injuries associated with these products.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions regarding the return or replacement of these specific lot numbers.
The recalled product
- Product
- Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 17
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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