Z-0352-03

Surgical Mesh

Name: Z-0352-03 Surgical Mesh
Creator: Synovis Surgical Inovation Div. of
Published: 2002-12-11
License: https://open.fda.gov/license/

SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) / initiated 2002-12-11 / Terminated / root cause: packaging

FDA source

Synovis Surgical Inovation Div. of began a recall of Surgical Mesh on 2002-12-11. The reason FDA records is "A gap in the exterior seal may lead to sterility concerns with the interior pouch". 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-0352-03
Status: Terminated
Initiated: 2002-12-11
Posted: 2015-06-25
Terminated: 2003-05-28
Recalling firm: SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)
Product: Surgical Mesh
Product code: 79F
Reason for recall: A gap in the exterior seal may lead to sterility concerns with the interior pouch.
Root cause tag: packaging
FDA 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 in commerce: 28 devices
Distribution: Product shipped nationwide, no foreign consignees
Product codes and lots: lot number 547628

Product code 79F

K002233Class IIBvi SlingBio-Vascular, Inc. / cleared 2000-10-13

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)