Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Defect
Zimmer Biomet is recalling specific CR Flex and Natural Knee prosthesis components because the LDPE packaging bag adheres to the polished implant surface.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 hazard involves packaging adhesion to the implant surface without reported injuries or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling specific CR Flex and Natural Knee prosthesis components, including femoral and tibial parts, due to a packaging defect. The Low-Density Polyethylene (LDPE) bag containing the implant adheres to the highly polished implant surface.
The affected products are distributed worldwide, including in the United States and numerous international locations. The recall covers various item numbers and lot numbers associated with these knee prosthesis components.
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
- CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 61,485
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 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 21 products in this recall →Related recalls
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Similar recalls
- ModerateZimmer Biomet Recalls Natural-Knee Flex Femoral Components Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Biomet Recalls Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Natural-Knee Flex Femoral Component Packaging Adhesion Recall
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- ModerateZimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Biomet Recalls CR-FLEX Knee Implants Due to Packaging Residue
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- ModerateZimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion
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