Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Defect
Zimmer Biomet is recalling 4,567 knee prosthesis units because the LDPE 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. The hazard is a packaging defect (adhesion) rather than a direct structural failure or contamination, and no injuries or illnesses are reported in the source text, fitting the Moderate criteria for low-risk or precautionary issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling 4,567 units of the PRCT MIS CR MOB PLT knee prosthesis. The device is a semi-constrained, metal/polymer, mobile bearing implant indicated for patients with severe knee pain and disability due to conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis.
The recall was initiated because the low-density polyethylene (LDPE) bag containing the implant adheres to the highly polished implant surface. This packaging defect is the specific reason for the recall action.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Argentina, Australia, Canada, and the United Kingdom. The recall covers specific item numbers and lot numbers listed in the official FDA record Z-0842-2016. Consumers and healthcare providers should check their inventory against the provided item and lot numbers to identify affected units.
The recalled product
- Product
- PRCT MIS CR MOB PLT 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, osteoarthritis, traumatic arthritis…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 4,567
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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