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 packaging.
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 without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling various knee systems used for knee joint arthroplasty and knee prosthesis. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products include numerous item numbers and were all 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 issue could potentially affect the handling or integrity of the implants during the packaging process.
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 for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008
- 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 product 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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