FDA Medical Device Recalls (openFDA)
Synovis Surgical Inovation Div. of: Surgical Mesh
- Recall number
- Z-0352-03
- Recalling firm
- Synovis Surgical Inovation Div. of
- Product
- Surgical Mesh
- Status
- Terminated
- Initiated
- 2002-12-11
- Posted
- not on file
- Terminated
- 2003-05-28
- Reason
- A gap in the exterior seal may lead to sterility concerns with the interior pouch.
- Root cause
- Other
- Action
- 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.
- Quantity
- 28 devices
- Distribution
- Product shipped nationwide, no foreign consignees
- Lot, serial or model codes
- lot number 547628
- 510(k) numbers
- ["K002233"]
- PMA numbers
- not on file
- Product code
- 79F
- Firm FEI
- 2183620
- Firm city
- St. Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28