Zimmer Manufacturing Recalls Hip Arthroplasty Components Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling specific hip arthroplasty components 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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific medical device components used in total or hemi hip arthroplasty. The recall affects products under product code JDI, including various sizes and extensions of the CPT 12/14 COCR series. The affected items are sterile.
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. The source text does not specify the number of affected units or report any illnesses or injuries associated with the use of these devices.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions regarding the return or replacement of these specific lots. The recall is distributed nationwide in the United States.
The recalled product
- Product
- Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 16
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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