Zimmer Biomet Recalls NexGen CR-FLEX Knee Implants Due to Packaging Defect
Zimmer Biomet is recalling NexGen CR-FLEX knee prostheses because the LDPE packaging bag adheres to the implant surface. The recall covers 42,064 units distributed worldwide.
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 is a packaging defect (bag adhesion) which is a quality control issue rather than a direct biological or mechanical failure of the implant itself, fitting the criteria for moderate severity involving minor defects or low-risk issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling NexGen CR-FLEX Option, Precoat, and Porous FEM knee prostheses. The recall is due to a defect where the low-density polyethylene (LDPE) bag containing the implant adheres to the highly polished implant surface. This issue affects 42,064 units of the device.
The affected products are semi-constrained, cemented knee prostheses indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis. The recall covers specific item numbers and lot numbers listed in the official FDA record. The devices were distributed nationwide in the United States and internationally to numerous countries including Argentina, Australia, Canada, and the United Kingdom.
Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to handle the affected devices. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheum
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 42,064
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
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 defect
See all →- HighMD Wipe Outz Numbing Tattoo Wipes Recalled for Child Poisoning Risk
CPSC · 2026-08-27
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12