Recall Z-2264-2013 ยท GCJ Laparoscope, General & Plastic Surgery
Endoplus, Inc.
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
| Date | Sep 21, 2013 (initiated Jul 15, 2013) |
| Status | Terminated |
| Reason | Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. |
| Root cause | Process control |
| Action | Letters were sent on 7/15/2013 to all customers notifying them of the recall. The letters requested that customers return the recalled devices via private courier using an enclosed account number. Replacement devices will be made available upon customer request. |
| Quantity | 81 units |
| Distribution | Distributed in the states of FL, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925079 | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) Endo Technic Corp., Aug 24, 1994 |