Zimmer Biomet Recalls NCB Proximal Lateral Tibia Implants
Zimmer Biomet is recalling NCB Proximal Lateral Tibia implants because non-highly polished devices may adhere to the packaging bag.
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 a packaging issue (adherence to the bag) rather than a direct structural defect or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling the NCB Proximal Lateral Tibia implants, specifically the "NCB-PT LAX PROX 3H TIBIA" in various sizes. The recall covers 5,459,583 total devices that were distributed nationwide. The affected products are all units manufactured prior to January 2014.
The recall was initiated because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue is associated with the specific packaging method used for these devices.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall and potential replacement of affected devices.
The recalled product
- Product
- NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313
- 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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