Zimmer Biomet Recalls Natural-Knee II Implants Due to Packaging Residue
Zimmer Biomet is recalling 13,227 Natural-Knee II knee implants because LDPE packaging may leave residue on the polished implant surfaces.
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 FDA classified this as a Class II recall. The hazard involves packaging residue on a medical device, which is a quality defect that could potentially affect device performance but is not explicitly linked to reported serious injuries or deaths in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of the Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating. The affected products include various sizes of left and right femoral components (SZ0, SZ2, and SZ3) with specific catalog and lot numbers.
The recall is due to a packaging defect where the LDPE bag may adhere to the highly polished surface of the implants. This adhesion can leave residue or material from the bag on the implant after it is removed from the packaging. The FDA has classified this as a Class II recall.
The affected implants were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Australia, Brazil, Canada, China, India, Japan, and others. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the return or replacement of these specific implant components.
The recalled product
- Product
- NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 13,227
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 48 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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