Zimmer Recalls Tibial Plates Due to Patient Label Discrepancies
Zimmer Inc. is correcting patient labels for NCB-PT tibial plates manufactured before March 2010 due to discrepancies in reference and lot numbers.
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 involves a labeling discrepancy where the source states the product label information is correct, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Zimmer Inc. is initiating a correction for the patient labels of NCB-PT lateral proximal 3 hole tibial plates. The affected products were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland.
The recall was initiated after the company received four complaints regarding a discrepancy between the product patient labels and the product labels concerning reference and lot numbers. The source text notes that while the information printed on the product label is correct, the discrepancy exists in the patient labels.
A total of 589 units are involved in this nationwide distribution. The affected products include specific reference numbers (02.02261.305, 02.02261.307, 02.02261.309, and 02.02261.313) and various lot numbers. Consumers and healthcare providers should verify the reference and lot numbers of their devices against the provided lists to determine if they are affected.
The recalled product
- Product
- NCB¿-PT lateral proximal 3 hole tibial plate
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 589
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 (18)
- REF Numbers: 02.02261.305
- 02.02261.307
- 02.02261.309
- and 02.02261.313. Lot:2442904
- 2341498
- 2402100
- 2407066
- 2414036
- 2422428
- 2426611
- 2434987
- 2442908
- 2387467
- 2402996
- 2407064
- 2422433
- 2450659
- 2450644
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by Zimmer, 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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