Recall Z-1434-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Conmed Corporation
ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Endoweave Multiple Use Grasper", 5 mm x 33 cm, REF/Product code 1-1028. -------- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
| Date | Aug 24, 2006 (initiated Mar 27, 2006) |
| Status | Terminated |
| Reason | Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures. |
| Root cause | Other |
| Action | On 3/27/06, all domestic customers were sent an "URGENT DEVICE RECALL" notice, dated 3/27/06, by USPS Priority Mail (Delivery Confirmation). International customers were notified by facsimile and/or e-mail as well as by mail. |
| Quantity | 3496 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924283 | MICROSURGE DETACHA-TIP SURGICAL INSTRUMENTS Microsurge, Inc., Apr 7, 1993 |