Zimmer Versys Hip Implant Recall Due to Insufficient Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling 1,220 units of Versus hip implants 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, which typically corresponds to a moderate severity score. The source text does not report any illnesses, injuries, or fatalities, and the hazard is related to calibration data rather than a confirmed contamination or defect causing harm.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 1,220 units of Versus CEM/REV/CALCAR hip implants. The affected products are sterile and were packaged in the firm's Building II between August 2010 and April 2013. The recall is being conducted because of insufficient sealer calibration data for these specific items.
The affected products include various sizes of the Versus CEM/REV/CALCAR system (13X, 15X, and 17X) used for total or hemi hip arthroplasty. The recall covers specific lot numbers listed in the official FDA record Z-1166-2016. The products were distributed nationwide in the United States.
Healthcare providers and patients should check their inventory and medical records for the specific lot numbers and product codes listed in the recall notice. If the affected products are in use, providers should contact Zimmer Manufacturing B.V. for instructions on replacement or removal. The FDA classifies this as a Class II recall, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 787101363 VERSYS CEM/REV/CALCAR 13X 787101560 VERSYS CEM/REV/CALCAR 15X 78710156
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 1,220
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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