Zimmer Inc. Recalls Anatomical Shoulder Humeral Stems Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Humeral 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. This aligns with the rubric criterion for 'Minor labeling errors' or 'voluntary precautionary recalls' where the hazard is administrative rather than a direct physical defect causing harm.
Plain-English summary
Zimmer Inc. is initiating a correction to the patient labels of Anatomical Shoulder Revision Humeral stems and Anatomical Shoulder Fracture Humeral stems. These products were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The recall involves 45 units distributed nationwide in the United States.
The correction is being made 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 of the implanted devices against the provided lists to ensure accurate documentation. The specific reference numbers involved are 01.04215.072, 01.04215.092, 01.04215.122, 01.04215.142, 01.04217.072, and 01.04217.132. The affected lot numbers are 2398402, 2485014, 2347028, 2380422, 2348099, 2341901, 2435527, and 2398475.
The recalled product
- Product
- Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 45
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 (13)
- REF Numbers: 01.04215.072
- 01.04215.092
- 01.04215.122
- 01.04215.142.
- 01.04217.072
- 01.04217.132 Lot 2398402
- 2485014
- 2347028
- 2380422
- 2348099
- 2341901
- 2435527
- 2398475
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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