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 hazard involves potential residue from packaging on medical implants, which is a moderate risk without reported injuries.
Plain-English summary
Zimmer Biomet, Inc. is recalling 13,227 units of CR-FLEX POR HATCP FEM hip and knee implants. The recall covers various sizes and configurations, including C, D, E, F, and G sizes in both left and right orientations.
The recall is due to a packaging issue 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 affected devices were distributed worldwide, including in the United States and countries such as Argentina, Australia, Brazil, Canada, China, India, Japan, and others. Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to handle the recalled devices.
The recalled product
- Product
- CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP FEM F-R CR-FLEX POR HATCP FEM G-L CR-FLEX POR HATCP FEM G-R This dev
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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