FDA Medical Device Recalls (openFDA)
Synovis Surgical Inovation Div. of: Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DG. Sterile, One Time Use, Contents 4 sets 1-guide rod, 23 mm, 250 mm long, dilating. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
- Recall number
- Z-1083-2007
- Recalling firm
- Synovis Surgical Inovation Div. of
- Product
- Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DG. Sterile, One Time Use, Contents 4 sets 1-guide rod, 23 mm, 250 mm long, dilating. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
- Status
- Terminated
- Initiated
- 2007-06-19
- Posted
- 2007-07-24
- Terminated
- 2012-05-08
- Reason
- There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
- Root cause
- Other
- Action
- Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.
- Quantity
- 19 boxes ( 76 units)
- Distribution
- Nationwide.
- Lot, serial or model codes
- 5729944-574729,5730453-586568
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDF
- Firm FEI
- 2183620
- Firm city
- Saint 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