Zimmer Recalls Metasul Durom Femoral Components Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for 209 Metasul Durom Femoral components after complaints of reference and lot number discrepancies.
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 no physical defect or harm is indicated.
Plain-English summary
Zimmer Inc. is initiating a correction to the patient labels of Metasul Durom Femoral components. These sterile, prescription-only products were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The recall involves 209 units distributed nationwide.
The action was taken after 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 in the patient labels.
Healthcare providers and patients should verify the reference and lot numbers of any implanted or stored components against the provided lists. Zimmer Inc. is the recalling firm responsible for this correction.
The recalled product
- Product
- Metasul¿ Durom¿ Femoral component Sterile, Rx
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 209
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: 01.00211.140
- 01.00211.144
- 01.00211.152
- 01.00211.154. 01.00211.156
- 01.00211.158
- and 01.00211.160. Lot: 2367454
- 2367454
- 2367455
- 2374382
- 2381632
- 2381634
- 2409055
- 2414048
- 2397713
- 2417888
- 2380622
- 2388389
- 2453506
- 2422704
- 2375235
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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