Zimmer NCB-PH Plate Label Correction for Reference and Lot Number Discrepancies
Zimmer, Inc. is correcting patient labels for NCB-PH Plates manufactured before March 2010 due to discrepancies in reference and lot numbers.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall addresses a documentation and labeling discrepancy where the source text explicitly states the information printed on the product label is correct, fitting the criteria for documentation issues or packaging-only problems.
Plain-English summary
Zimmer, Inc. is initiating a correction to the patient labels of NCB-PH Plates manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. This action follows four complaints regarding discrepancies between product patient labels and 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 labeling documentation. The affected products are identified by REF Numbers 02.02262.105 and 02.02262.107, and Lot 2450659 and 2450644. A total of 95 units were distributed nationwide.
Consumers and healthcare providers should verify the reference and lot numbers on their NCB-PH Plates against the provided codes to determine if they are affected by this labeling correction.
The recalled product
- Product
- NCB¿-PH Plate
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 95
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 (2)
- REF Numbers: 02.02262.105 and 02.02262.107. Lot 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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