Zimmer Biomet Recalls NexGen LPS Flex Femoral Knee Implants
Zimmer Biomet is recalling NexGen LPS Flex femoral knee implants because the 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, which typically indicates a moderate risk. The specific defect is a packaging issue (bag adhesion) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling NexGen LPS Flex Option Femoral and NexGen LPS Flex Precoat Femoral prostheses. These are knee implants indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis.
The recall is due to a defect where the LDPE bag containing the implant adheres to the highly polished implant surface. The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries.
Consumers and healthcare providers should contact Zimmer Biomet for further instructions on how to handle the affected devices.
The recalled product
- Product
- NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing 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
- 115,796
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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