Zimmer Anatomical Shoulder Humeral Head Label Correction
Zimmer, Inc. is correcting patient labels for Anatomical Shoulder Humeral Heads 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 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 labeling discrepancy where the source text explicitly states the information printed on the product label is correct, fitting the rubric for documentation issues or packaging-only problems.
Plain-English summary
Zimmer, Inc. is initiating a correction to the patient labels of Anatomical Shoulder Humeral Head products. This action involves 224 units manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The products 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 discrepancy specifically concerns the reference and lot numbers of the product. The source text notes that the information printed on the product label is correct.
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 specific REF numbers and Lots affected are listed in the official recall documentation.
The recalled product
- Product
- Anatomical Shoulder" Humeral Head
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 224
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: 01.04212.400
- 01.04212.420
- 01.04212.440
- 01.04212.460
- 01.04212.480
- 01.04212.500
- 01.04213.480
- and 01.04213.520. LotsLots: 2335921
- 2388114
- 2475819
- 2444895
- 2485536
- 2397602
- 2437195
- 2485540
- 2397014
- 2408970
- 2483098
- 2370444
- 2437201
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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