Zimmer Recalls Alloclassic SL Shafts for Labeling Discrepancies
Zimmer, Inc. is correcting patient labels for Alloclassic SL Shafts 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 'Minor labeling errors' criterion for a Moderate score.
Plain-English summary
Zimmer, Inc. is initiating a correction for the patient labels of Alloclassic SL Shaft products. This action affects 1,355 units manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, which were distributed nationwide.
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 was identified in the patient labels.
Consumers and healthcare providers should verify the reference and lot numbers on the patient labels against the product labels for these specific items to ensure accurate patient records.
The recalled product
- Product
- Alloclassic SL Shaft
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 1,355
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 (20)
- Item 2839
- 2840
- 2841
- 2842
- 2843
- 2844
- 2845
- 2846
- 2847
- 2848
- 2949
- 2851
- 2852
- 2883
- 2884
- 2885
- 2886
- and 2887 Lots: 2359249
- 2359251
- 2368739
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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