Zimmer Biomet Recalls NCB Periprosthetic Proximal Femoral Plates
Zimmer Biomet is recalling NCB Periprosthetic Proximal Femoral Plates because non-highly polished implants 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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The specific hazard is a packaging issue where implants may adhere to the bag, which is a moderate risk without reported injuries.
Plain-English summary
Zimmer Biomet, Inc. is recalling the NCB Periprosthetic "NCB PP Prox Fem Plate" in various sizes. The recall covers 5,459,583 total devices 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 could potentially affect the handling or integrity of the device during storage or preparation.
Healthcare providers and facilities that have received these devices should stop using them and contact Zimmer Biomet for instructions on how to return or dispose of the product. Patients who have already had these implants placed should consult their healthcare provider if they have concerns.
The recalled product
- Product
- NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 020226
- Manufacturer
- Zimmer Biomet, Inc.
- 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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