Zimmer Manufacturing Recalls Unipolar Endo Femoral Heads Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling specific unipolar endo femoral heads used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
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 high-risk medical device (implant) with a potential safety issue (insufficient calibration data) but no reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Manufacturing B.V. is recalling Product 64, which consists of all product under product code JDI, specifically Item no. 902605101 Unipolar Endo Fem Head 51MM. These devices are intended for use in hemi hip arthroplasty. The recall is limited to products packaged in the firm's Building II between August 2010 and April 2013.
The recall was initiated because of insufficient sealer calibration data for the affected sterile products. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of these devices.
Healthcare providers and facilities should identify and stop using the affected lots. Consumers who have had these devices implanted should contact their healthcare provider for guidance. The recall is distributed nationwide in the US.
The recalled product
- Product
- Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip arthroplasty
- Manufacturer
- Zimmer Manufacturing B.V.
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 (1)
- lot no.: 62054883
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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