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.
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 packaging adhesion to the implant surface without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling NexGen LPS-FLEX Option Femoral and NexGen LPS-FLEX Precoat Femoral 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.
The affected devices are indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis. The recall covers 117,359 units 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 further instructions regarding the return or replacement of these devices. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumato
- Manufacturer
- Zimmer Biomet, Inc.
- Category
- Medical Device — Knee Prosthesis
- Hazard
- Affected units
- 117,359
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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