Surgical Mesh
Hazard
A gap in the exterior seal may lead to sterility concerns with the interior pouch.
What You Should Do
Remedy
The sites and/or distributors that received suspect devices were contacted by telephone on 12/11/02 and given instructions on how to return/replace the devices. In addition, a letter dated 12/11/02 was sent to each consignee.
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Products
Surgical Mesh
- Brand
- Synovis Surgical Inovation Div. of
- UPC
- lot number 547628
Units Affected
28 devices