Zimmer Manufacturing Recalls Hip Arthroplasty Femoral Heads Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 366 units of 6 Degree COCR Femoral Heads used in hip arthroplasty due to insufficient sealer calibration data.
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, but the source text explicitly states no illnesses or injuries are reported and the hazard is related to calibration data rather than a confirmed defect causing harm, fitting the criteria for a moderate voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 366 units of 6 Degree COCR Femoral Heads (product code JDI) used in total or hemi hip arthroplasty. 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 covers specific item numbers including 902602500, 902602600, 902602700, 902602800, 902602900, 902603000, 902603300, and 902603200. The distribution pattern is listed as US Nationwide Distribution. Specific lot numbers associated with this recall include 61603870, 60973105N, 60892289N, 60900891N, 62279763, 62093449, 62185961, 62279764, 62384218, 62082438, 62268537, and 62384219.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions regarding the return or replacement of these devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COCR FEM HEAD 26 902602800 6 DEGREE COCR FEM HEAD 28 902602900 6 DEGREE COCR FEM HEAD 28 902603
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 366
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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