Zimmer Recalls Anatomical Shoulder Inverse Humeral Cups for Labeling Discrepancies
Zimmer, Inc. is correcting patient labels for 66 Anatomical Shoulder Inverse Humeral Cups 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 regarding reference and lot numbers. The source text does not report any injuries, illnesses, or deaths, and the hazard is limited to documentation and labeling accuracy rather than a functional defect or contamination.
Plain-English summary
Zimmer, Inc. is initiating a correction for 66 units of the Anatomical Shoulder Inverse Humeral Cup. These specific medical devices were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, and 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. The complaints noted inconsistencies in the reference and lot numbers printed on the labels. The source text indicates that while the information printed on the product label is correct, the discrepancy exists between the two label types.
This correction applies to units with REF Numbers 01.04223.100, 01.04223.106, 01.04223.111, 01.04223.121, 01.04223.190, and 01.04223.196, and Lot Numbers 2310656, 2429295, 2468509, 2310648, 2410046, 2486362, 2474203, and 2317777. Healthcare providers and patients should verify the reference and lot numbers of their devices against this list to determine if they are affected.
The recalled product
- Product
- Anatomical Shoulder" Inverse Humeral Cup
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 66
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: 01.04223.100
- 01.04223.106
- 01.04223.111
- 01.04223.121
- 01.04223.190
- and 01.04223.196.Lot 2310656
- 2429295
- 2468509
- 2310648
- 2410046
- 2486362
- 2474203
- 2317777
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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