Recall Z-1150-2007 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Zinnanti Surgical Design LLC
Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils.
| Date | Aug 14, 2007 (initiated Jul 12, 2007) |
| Status | Terminated |
| Reason | Bubble Leak Test Failure of sterility barrier, therefore sterility of the device may be compromised |
| Root cause | Other |
| Action | The recalling firm issued an Urgent Medical Device Recall Letter dated 7/24/07 to its single wholesaler requesting recall and sub-recall to all their consignees. |
| Quantity | 8, 860 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930511 | STEALTH SURGICAL IRRIGATOR ASPIRATOR W. J. Medical Instruments, Inc., Jun 25, 1993 |