Zimmer Biomet Recalls Sterile Implants Due to Packaging Design Failures
Zimmer Biomet is recalling 87 units of sterile implants because packaging design verification tests failed. The action covers domestic and international distribution.
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. The hazard is a packaging design verification failure, which is a precautionary measure to ensure sterility, but no specific illnesses or injuries are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is initiating a field action for 87 units of the 4.5 BROAD SCP PLT 26-H STER implant. The recall is due to packaging design verification test failures for sterile-packaged implants in a single package configuration.
The affected products were distributed domestically to numerous U.S. states and territories, as well as to various foreign countries including Canada, Australia, and locations in Europe, Asia, and the Americas. The specific item number for the recalled product is 47494502601.
Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these specific sterile implants.
The recalled product
- Product
- 4.5 BROAD SCP PLT 26-H STER
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 87
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 (3)
- 510K: K101073
- P
- K113224 Item Numbers: 47494502601
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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