Surgical Mesh
This recall has been terminated (originally issued December 11, 2002).
- Recall Initiated
- December 11, 2002
- Terminated
- May 28, 2003
- Recall Number
- Z-0352-03
- Quantity
- 28 devices
- Firm Location
- St. Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
A gap in the exterior seal may lead to sterility concerns with the interior pouch.
Distribution
Product shipped nationwide, no foreign consignees
Lot / Code Info
lot number 547628
Root Cause
Other
Action Taken
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.