Zimmer MS-30 Stem Recall for Patient Label Discrepancies
Zimmer Inc. is correcting patient labels for MS-30 Stems 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 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, but the source text explicitly states that the information printed on the product label is correct and the issue is a labeling discrepancy, fitting the criteria for minor labeling errors.
Plain-English summary
Zimmer Inc. is initiating a correction for the MS-30 Stem, a medical device manufactured by Zimmer GmbH in Winterthur, Switzerland. The recall affects products manufactured before March 2010 that were distributed nationwide.
The correction is being made after the company received four complaints regarding a discrepancy between the product patient labels and the product labels. Specifically, the complaints noted differences in the reference and lot numbers. The source text indicates that the information printed on the product label is correct.
The affected products are identified by REF Numbers 01.00351.005 and 01.00351.006, and lots 2330077 and 2397912. Patients and healthcare providers should verify the labeling on their devices to ensure they match the correct reference and lot numbers.
The recalled product
- Product
- MS-30¿ Stem
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 30
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 (4)
- REF Numbers: 01.00351.005
- 01.00351.006
- lots 2330077
- 2397912
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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