Zimmer Biomet Recalls Knee Prosthesis Due to Packaging Adhesion Issue
Zimmer Biomet is recalling Zimmer Uni High Flex Precoat Femoral knee prostheses because the LDPE 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 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, 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 Zimmer Uni High 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 painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis, previous tibial condyle or plateau fractures, varus or valgus deformities, or revision of previous arthroplasty procedures. The devices are designed for cemented use only.
The recall involves 32,537 units distributed worldwide, including the United States and numerous international locations. Consumers and healthcare providers should contact Zimmer Biomet for further instructions on handling the affected devices.
The recalled product
- Product
- ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 32,537
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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Similar recalls
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