Zimmer Biomet Recalls LPS-FLEX GSF OPT Knee Prostheses Due to Packaging Defect
Zimmer Biomet is recalling LPS-FLEX GSF OPT knee prostheses because the LDPE bag adheres to the implant surface. The recall covers 84,396 units distributed worldwide.
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. The hazard is a packaging defect (bag adhesion) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 84,396 units of LPS-FLEX GSF OPT knee prostheses. The recall is due to a defect where the 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, or traumatic arthritis. The recall covers various sizes of the prosthesis, which is a semi-constrained, cemented, polymer/metal/polymer device.
The affected units were distributed nationwide in the US and internationally to numerous countries including Argentina, Australia, Austria, and Canada. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- Product
- LPS-FLEX GSF OPT 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: Rheumatoid arthritis, osteoarthritis, traumatic…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 84,396
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.
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