FDA Device

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.

Products

Surgical Mesh
Brand
Synovis Surgical Inovation Div. of
UPC
lot number 547628

Units Affected

28 devices