Zimmer Biomet Recalls Knee Implants Due to Packaging Residue
Zimmer Biomet is recalling 13,227 Natural-Knee Flex System 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 potential quality issue but does not involve high-risk pathogens or reported serious injuries, fitting the Moderate criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of the Gender Solutions Natural-Knee Flex System Female (GSF) Femoral Component, nonporous. The affected components are distributed worldwide, including the United States and 23 other countries.
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.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to handle the affected devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use
- 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
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · packaging residue
See all →- ModerateZimmer Biomet Recalls Versus Hip Stems Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Biomet Recalls Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Biomet Recalls Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Biomet Recalls Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21