Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.
FDA Recall Z-0862-2009 · Posted 2009-02-20
Recalling FirmMiltex, Inc.
Recall StatusTerminated
Product CodeGES
Date Initiated2008-11-17
Date Terminated2009-02-23
Product Quantity200 boxes
Reason for Recall
Blade may break: Over milling of the blade resulted in tip more narrow than specified.
Firm Action
An Urgent Medical Device Recall letter dated 11/17/08 with an accompanying fax back form was sent to each customer. Each distributor was instructed to review their inventory, complete the form, and return any affected product. The distributors were also instructed to conduct a sub recall notification.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.