Zimmer Recalls Wagner SL Revision Stems for Labeling Discrepancies
Zimmer Inc. is correcting patient labels for Wagner SL Revision Stems 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 rather than a functional defect or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Zimmer Inc. is initiating a correction for the patient labels of Wagner SL Revision Stem, uncemented Sterile products. The affected units were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. A total of 87 units 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 numbers of the affected devices against the list provided in the official recall notice. The specific REF numbers involved include 01.00101.914, 01.00101.915, 01.00101.916, 01.00101.917, 01.00101.918, 01.00102.217, 01.00102.219, 01.00102.221, 01.00102.619, 01.00102.620, 01.00102.621, 01.00102.622, 01.00103.015, 01.00103.017, 01.00103.021, 01.00103.025, 30.00.89.160, and 30.00.89.190.
The recalled product
- Product
- Wagner SL Revision Stem, uncemented Sterile
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 87
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 (18)
- REF Numbers: 01.00101.914
- 01.00101.915
- 01.00101.916
- 01.00101.917
- 01.00101.918
- 01.00102.217
- 01.00102.219
- 01.00102.221
- 01.00102.619
- 01.00102.620
- 01.00102.621
- 01.00102.622
- 01.00103.015
- 01.00103.017
- 01.00103.021
- 01.00103.025
- 30.00.89.160
- and 30.00.89.190.
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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