Zimmer Biomet Recalls Natural-Knee Flex Femoral Components Due to Packaging Residue
Zimmer Biomet is recalling 13,227 Natural-Knee Flex femoral components because LDPE packaging may leave residue on the polished implant surface.
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 involves packaging residue on a medical device, which is a quality defect that could potentially affect device performance or safety, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of the Gender Solutions Natural-Knee Flex System Femoral Component. The affected components are sizes 2 through 5, in both left and right configurations, and feature CSTi porous coating. These components are indicated for uncemented or cemented use in skeletally mature individuals undergoing primary knee surgery for degenerative or inflammatory joint disease.
The recall is due to a packaging defect where the LDPE bag may adhere to the highly polished surface of the implant. This adhesion can leave residue or material from the bag on the implant after it is removed from the packaging. The affected products were distributed worldwide, including in the United States and numerous international markets.
No specific consumer action is detailed in the provided source text beyond the identification of the defect. Healthcare providers and facilities should verify their inventory against the specific lot codes listed in the official recall notice to ensure no affected components are used in surgical procedures.
The recalled product
- Product
- GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi p
- 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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