Recall Z-2744-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Cambridge Endoscopic Devices, Incorporated
Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cm Catalog Number: LA1101-12 Intended for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.
| Date | Jul 6, 2011 (initiated May 20, 2011) |
| Status | Terminated |
| Reason | PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors |
| Root cause | Process control |
| Action | Cambridge Endoscopic Devices, Inc. sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 20, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to return unused inventory using RGA Number 301. Returned devices will be replaced. Questions regarding this recall, call 508-405-0790 for assistance. |
| Quantity | 255 units |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Armenia , Australia, Austria, Chile, China, Denmark, Hong Kong, India, Ireland , Italy, Japan, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061425 | PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01 Cambridge Endoscopic Devices, Aug 10, 2006 |