Ethicon Recalls Silk Sutures Due to Potential Shelf Life Deficiency
Ethicon, Inc. is recalling specific lots of PERMA-HAND/MERSILK and VIRGIN SILK Blue twisted Silk Sutures because they may not meet the required 5-year shelf life.
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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific hazard is a potential failure to meet shelf life requirements, which is a quality control issue rather than an immediate physical hazard like a defect causing injury.
Plain-English summary
Ethicon, Inc. is recalling 99,612 units of PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, size 8-0 Blue twisted Silk Sutures. The recall involves specific product codes and lots identified in the agency's structured data. The reason for the recall is that these lots may not meet the stringent full shelf life of 5 years.
The affected products were not distributed domestically in the United States. Instead, they were distributed to various foreign countries, including Canada, the United Kingdom, Germany, France, and Australia, among others. The source text does not specify the exact number of units distributed to each country or the specific dates of distribution.
Healthcare providers and facilities that have received these products should stop using them and contact Ethicon, Inc. for further instructions on how to return or dispose of the affected sutures. Patients who have already received these sutures should consult their healthcare provider if they have concerns regarding the shelf life of the product.
The recalled product
- Product
- PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
- Manufacturer
- Ethicon, Inc.
- Hazard
- Affected units
- 99,612
Distribution
Distribution scope not specified by the agency.
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