Zimmer Inc. Recalls MS-30 Proximal Positioners Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for MS-30 Proximal Positioners 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 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 MS-30 Proximal Positioner, a medical device manufactured by Zimmer GmbH in Winterthur, Switzerland. The recall affects five units that were distributed nationwide and manufactured before March 2010. The specific reference number is 01.00351.265 and the lot number is 237973.
The action was taken 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 was identified in the patient labels.
Healthcare providers and patients should verify the reference and lot numbers on their devices against the recall details. If the device matches the affected lot, providers should contact Zimmer Inc. for further instructions regarding the label correction.
The recalled product
- Product
- MS-30¿ Proximal positioner
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 5
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 Number: 01.00351.265
- lot 237973
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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