Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished 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 recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of CR Option Femoral Components, which are hip and knee implants indicated for patients with severe knee pain and disability. The recall covers various sizes and configurations (C through G, left and right) distributed worldwide, including the United States and numerous international markets.
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.
No specific consumer actions are detailed in the provided source text, but the recall is initiated to address the potential for foreign material residue on the medical devices.
The recalled product
- Product
- CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FEM COMP SIZE F/L CR OPTION FEM COMP SIZE F/R CR OPTION FEM COMP SIZE G/L CR OPTION FEM COMP
- 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.
See all 48 products in this recall →Related recalls
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