Surgical Mesh
FDA Recall Z-0352-03 · Posted None
Recalling FirmSynovis Surgical Inovation Div. of
Recall StatusTerminated
Product Code79F
Date Initiated2002-12-11
Date Terminated2003-05-28
Product Quantity28 devices
Reason for Recall
A gap in the exterior seal may lead to sterility concerns with the interior pouch.
Firm 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.
Root Cause
Other
Distribution Pattern
Product shipped nationwide, no foreign consignees
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.