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.
FDA Recall Z-2744-2011 · Posted 2011-07-06
Advertisement
Recalling FirmCambridge Endoscopic Devices, Incorporated
Recall StatusTerminated
Product CodeGEI
Date Initiated2011-05-20
Date Terminated2012-07-24
Product Quantity255 units
Reason for Recall
PET shrink sleeve insulation material dislodging
from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement