Zimmer Biomet Recalls Sterile-Implant Tubes Due to Packaging Design Failures
Zimmer Biomet is recalling 510 units of sterile-packaged VERSA-FX II STD TUBE implants because packaging design verification tests failed.
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 the issue is a packaging design verification test failure without reporting any illnesses or injuries, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
Zimmer Biomet, Inc. is initiating a field action for 510 units of sterile-packaged VERSA-FX II STD TUBE implants. The affected product models include various sizes such as 130DX16H, 135DX18H, and 150DX20H. The recall is being conducted because the packaging design verification tests failed.
The affected units were distributed domestically across numerous U.S. states and territories, including Puerto Rico, and internationally to countries such as Canada, Australia, and Germany. The source text does not specify any reported illnesses, injuries, or deaths associated with this field action.
Consumers and healthcare providers should stop using the affected sterile-packaged implants and contact Zimmer Biomet for further instructions regarding the field action.
The recalled product
- Product
- VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 510
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 510K:K150818
Distribution
Part of a larger recall action
This product is one of 8 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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