Zimmer Biomet Recalls DVR Crosslock ePAK Screw Drivers Due to Packaging Seal Risk
Zimmer Biomet is recalling 3,022 DVR Crosslock ePAK Screw Drivers because sterile packaging seals may be weak, potentially compromising sterility.
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, and the hazard is a potential packaging defect (weak seals) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,022 units of the DVR Crosslock ePAK Screw Driver, Model Number 212000002. These disposable instruments are used to facilitate the implantation of orthopedic medical devices in trauma settings. The recall is due to a potential for weak seals in the sterile packaging.
The affected products were distributed worldwide, including nationwide in the United States and in Australia, Canada, Chile, Japan, and the Netherlands. Specific lot numbers are listed in the agency's recall record.
Consumers and healthcare facilities should stop using the affected products and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 3,022
Distribution
Part of a larger recall action
This product is one of 3 recalled by Zimmer Biomet, Inc. 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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