Zimmer Anatomical Shoulder Humeral Stem Label Correction
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Humeral 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and labeling discrepancy where the source text explicitly states the information printed on the product label is correct, fitting the criteria for documentation issues.
Plain-English summary
Zimmer Inc. is initiating a correction for Anatomical Shoulder Humeral stems manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. 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 through these complaints. The recall involves 260 units distributed nationwide.
Consumers and healthcare providers should verify the reference and lot numbers of the implanted devices against the provided lists to ensure accurate patient records.
The recalled product
- Product
- Anatomical Shoulder" Humeral stem
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 260
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 (20)
- REF Numbers: 01.04201.072
- 01.04201.092
- 01.04201.102
- 01.04201.122
- 01.04201.142
- 01.04211.072
- 01.04211.092
- 01.04211.122
- and 01.04211.142 Lot 2333904
- 2403849
- 2416919
- 2443150
- 2327341
- 2452413
- 2320506
- 2323574
- 2364979
- 2373235
- 2406171
- 2416913
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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