Zimmer Recalls Anatomical Shoulder Fracture Humeral Stems for Label Discrepancies
Zimmer, Inc. is correcting patient labels for 139 Anatomical Shoulder Fracture Humeral stems due to discrepancies between product and patient labels regarding 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 addresses a documentation and labeling discrepancy where the source text explicitly states the product label information is correct, fitting the rubric for documentation issues or packaging-only problems.
Plain-English summary
Zimmer, Inc. is initiating a correction for 139 Anatomical Shoulder Fracture Humeral stems manufactured before March 2010 at the Zimmer GmbH production site in Winterthur, Switzerland. The recall was initiated after the company received four complaints regarding a discrepancy between the product patient labels and the product labels with respect to reference and lot numbers.
The source text notes that while the information printed on the product label is correct, the discrepancy exists in the patient labels. The affected products were distributed nationwide.
Consumers and healthcare providers should verify the reference and lot numbers of the implanted or stored devices against the specific REF numbers and lot numbers listed in the official recall notice to determine if their products are affected.
The recalled product
- Product
- Anatomical Shoulder" Fracture Humeral stem
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 139
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: 01.04207.072
- 01.04207.082
- 01.04207.092
- 01.04207.112
- 01.04207.132
- 01.04207.142
- 01.04217.072
- and 01.04217.132. Lot 2360479
- 2373842
- 2331163
- 2401526
- 2458833
- 2360473
- 2451660
- 2387138
- 2521377
- 2342166
- 2455419
- 2342646
- 2436406
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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