Z-1083-2007

Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DG. Sterile, One...

Name: Z-1083-2007 Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DG. Sterile, One...
Creator: Synovis Surgical Inovation Div. of
Published: 2007-06-19
License: https://open.fda.gov/license/

SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) / initiated 2007-06-19 / Terminated / root cause: packaging

FDA source

Synovis Surgical Inovation Div. of began a recall 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... on 2007-06-19. The reason FDA records is "There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1083-2007
Status: Terminated
Initiated: 2007-06-19
Posted: 2007-07-24
Terminated: 2012-05-08
Recalling firm: SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)
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
Product code: GDF Guide, Needle, Surgical
Reason for recall: There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
Root cause tag: packaging
FDA 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 in commerce: 19 boxes ( 76 units)
Distribution: Nationwide.
Product codes and lots: 5729944-574729,5730453-586568

Product code GDF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)