Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion
Zimmer Biomet is recalling NexGen Knee CR femoral components because the packaging bag adheres to the 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because the hazard is a packaging-only problem (bag adhesion) with no reported injuries or illnesses, fitting the rubric criteria for cosmetic or packaging defects.
Plain-English summary
Zimmer Biomet, Inc. is recalling NexGen Knee CR Porous FEM and NexGen Knee CR Precoat FEM prostheses. The recall involves 18,093 units of these knee implants, which are indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis.
The reason for the recall is that the low-density polyethylene (LDPE) bag containing the implant adheres to the highly polished implant surface. This defect is a packaging issue that affects the physical state of the device upon receipt.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Argentina, Australia, Canada, and the United Kingdom. Consumers and healthcare providers should check their inventory for the specific item and lot numbers listed in the official recall notice and contact Zimmer Biomet for instructions on how to proceed.
The recalled product
- Product
- NexGen Knee CR Porous FEM NexGen Knee CR Precoat 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: Rheumatoid arthritis…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 18,093
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
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