Zimmer Anatomical Shoulder Ball Taper Label Correction
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Ball Tapers 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 Anatomical Shoulder Ball Tapers for humeral stems manufactured before March 2010 at the Zimmer GmbH production site in Winterthur, Switzerland. The recall involves 54 units distributed nationwide.
The correction is being made after the company received four complaints regarding discrepancies between the product patient labels and the product labels concerning reference and lot numbers. The source text notes that the information printed on the product label is correct.
Affected units are identified by REF Numbers 01.04227.102 and Lot Numbers 2350372, 2381792, 2398201, 2452078, and 2460783. Healthcare providers and patients should verify the labeling on these specific devices.
The recalled product
- Product
- Anatomical Shoulder" Ball taper for humeral stem
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 54
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 (6)
- REF Numbers: 01.04227.102
- Lot:2350372
- 2381792
- 2398201
- 2452078
- 2460783
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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