Zimmer Manufacturing Recalls Sterile Hip Arthroplasty Stems Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling sterile cemented femoral stems for hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
What this means for you
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. The hazard is a process deviation (insufficient sealer calibration data) rather than a confirmed defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific lots of sterile cemented femoral stems (CEM FEM ST) intended for use in total or hemi hip arthroplasty. The recall is initiated 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 covers specific item numbers including 765301101 through 765301601 and 763301300, 763301600. The distribution pattern is listed as US Nationwide Distribution. Specific lot numbers are identified in the recall documentation, including 62222763, 62240266, and others.
Healthcare providers and facilities should check their inventory for the affected product codes and lot numbers. If the products are found, they should be removed from use and returned to the manufacturer or follow the specific instructions provided by Zimmer Manufacturing B.V. for the recall.
The recalled product
- Product
- Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145
- 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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