Z-0862-2009

Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in...

Name: Z-0862-2009 Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in...
Creator: Miltex, Inc.
Published: 2008-11-17
License: https://open.fda.gov/license/

Miltex, Inc. / initiated 2008-11-17 / Terminated / root cause: manufacturing process

FDA source

Miltex, Inc. began a recall of Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades on 2008-11-17. The reason FDA records is "Blade may break: Over milling of the blade resulted in tip more narrow than specified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0862-2009
Status: Terminated
Initiated: 2008-11-17
Posted: 2009-02-20
Terminated: 2009-02-23
Recalling firm: Miltex, Inc.
Product: Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.
Product code: GES Blade, Scalpel
Reason for recall: Blade may break: Over milling of the blade resulted in tip more narrow than specified.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 200 boxes
Distribution: Nationwide Distribution and Canada.
Product codes and lots: Lot number S07C06

Product code GES

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)