Zimmer Recalls Distal Centralizers Due to Labeling Discrepancy Complaints
Zimmer Inc. is correcting patient labels for MS-30 Distal Centralizers manufactured before March 2010 after receiving four complaints regarding reference and lot number discrepancies.
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 2/5 (Moderate).
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 without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Inc. is initiating a correction to the patient labels of MS-30 Distal Centralizers, cemented, sterile, prescription products. This action involves 58 units manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The products were distributed nationwide.
The recall was initiated after the company received four complaints identifying a discrepancy between the product patient labels and the product labels regarding reference and lot numbers. The source text notes that while the information printed on the product label is correct, the discrepancy was reported in the context of the patient labels.
Healthcare providers and patients should verify the reference and lot numbers of the affected devices against the provided lists. The specific reference numbers involved are 01.00351.005, 01.00351.006, 01.00351.014, 01.00351.214, 01.00351.216, 01.00351.416, 01.00351.620, 01.00356.008, and 01.00356.010. The affected lot numbers are 2330077, 2397912, 2319413, 2280640, 2386348, 2399448, 2389980, and 2426020, 2430035.
The recalled product
- Product
- MS-30¿ Distal centralizer, cemented, sterile, Rx
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 58
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 (17)
- REF Numbers: 01.00351.005
- 01.00351.006
- 01.00351.014
- 01.00351.214
- 01.00351.216
- 01.00351.416
- 01.00351.620
- 01.00356.008
- 01.00356.010.Lot 2330077
- 2397912
- 2319413
- 2280640
- 2386348
- 2399448
- 2389980
- 2426020
- and 2430035.
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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