Zimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion
Zimmer Biomet is recalling various knee systems because non-highly polished implants may adhere to the LDPE bag.
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) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving low-risk contamination or packaging issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling various knee systems, identified by specific item numbers, due to a packaging issue. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products were manufactured prior to January 2014.
The reason for the recall is that non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This adhesion could potentially affect the handling or integrity of the implant prior to use.
Healthcare providers and facilities that have received these devices should stop using them and contact Zimmer Biomet for further instructions on how to proceed with the recall.
The recalled product
- Product
- Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 32855430503 32855430511 32855430526 32855430530 32855430531…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,459,583
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All products manufactured prior to January 2014.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 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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