Zimmer Recalls Anatomical Shoulder Implants Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for 228 anatomical shoulder implants manufactured before March 2010 due to reported discrepancies between product and patient labels.
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 physical defect or reported injury, fitting the criteria for minor labeling errors.
Plain-English summary
Zimmer Inc. is initiating a correction for 228 units of the Anatomical Shoulder Inverse/Reverse Glenoid Sterile, Rx. The affected products were manufactured before March 2010 at 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 reference and lot numbers printed on the product labels and the patient labels. The source text notes that the information printed on the product label is correct.
Healthcare providers and patients should verify the reference and lot numbers of the implanted devices against the provided list to determine if they are affected. The specific reference numbers are 01.04223.200 and 01.04223.236, and the lot numbers include 2313338, 2314443, 2318819, 2331464, 2342906, 2343151, 2346399, 2368714, 2387755, 2425692, 2468583, 2468587, 2471765, 2503386, and 2516402.
The recalled product
- Product
- Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 228
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 (15)
- REF Numbers: 01.04223.200 and 01.04223.236 2313338
- 2314443
- 2318819
- 2331464
- 2342906
- 2343151
- 2346399
- 2368714
- 2387755
- 2425692
- 2468583
- 2468587
- 2471765
- 2503386
- 2516402
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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