Zimmer Recalls 18 CLS Stem Implants Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for 18 CLS Stem implants manufactured before March 2010 due to discrepancies in reference and lot numbers.
What this means for you
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, but the source text explicitly states that the information printed on the product label is correct and the issue is a labeling discrepancy. This aligns with the rubric for 'Minor labeling errors' or 'voluntary precautionary recalls' where the physical product is not defective, resulting in a Moderate severity score.
Plain-English summary
Zimmer Inc. is initiating a correction for 18 units of the CLS Stem medical device. These 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 product patient labels and the product labels. Specifically, the complaints noted inconsistencies in the reference and lot numbers. The source text indicates that while the information printed on the product label is correct, the discrepancy exists in the labeling documentation.
The affected units are identified by REF Numbers 29.00.09.137, 29.00.09.162, 29.00.39.070, and 29.00.39.125, and Lot Numbers 2397894, 2393484, 2480480, and 2439729. Consumers and healthcare providers should verify the reference and lot numbers of their CLS Stem implants against this list to determine if they are affected.
The recalled product
- Product
- CLS Stem
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 18
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 (7)
- REF Numbers: 29.00.09.137
- 29.00.09.162
- 29.00.39.070
- and 29.00.39.125 Lot 2397894
- 2393484
- 2480480
- 2439729
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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