Recall Z-0862-2009 ยท GES Blade, Scalpel
Miltex, Inc.
Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.
| Date | Feb 20, 2009 (initiated Nov 17, 2008) |
| Status | Terminated |
| Reason | Blade may break: Over milling of the blade resulted in tip more narrow than specified. |
| 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 | 200 boxes |
| Distribution | Nationwide Distribution and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.