Zimmer Biomet Recalls DVR Crosslock ePAK Depth Gauges for Packaging Defects
Zimmer Biomet is recalling DVR Crosslock ePAK Depth Gauges due to a potential for weak seals in the sterile packaging.
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 there is only a 'potential' for weak seals and does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling DVR Crosslock ePAK Depth Gauges, Model Number 212000003. These disposable instruments are used to facilitate the implantation of orthopedic medical devices in trauma settings.
The recall is being conducted because there is a potential for weak seals in the sterile packaging. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
A total of 3,022 units were distributed worldwide, including across the United States and in Australia, Canada, Chile, Japan, and the Netherlands. The affected lot numbers are: 226646, 230493, 231877, 232682, 235476, BFI0LBKR, 187763, 193566, BF10LBK, BFA012345, BFI0LBK, BFI0M4H, BFI0M9F, BFI0N13, BFI0N14, BFION15, I0N12, I0N12R, I0N13, BF10M9F, and BFIOLBK.
The recalled product
- Product
- DVR Crosslock ePAK Depth Gauge, Model Number 212000003 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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