Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 34cm Catalog Number: LA1101-01 Intended for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.
This recall has been terminated (originally issued July 6, 2011).
- Recall Initiated
- May 20, 2011
- Posted
- July 6, 2011
- Terminated
- July 24, 2012
- Recall Number
- Z-2743-2011
- Quantity
- 647 units
- Firm Location
- Framingham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors
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.
Lot / Code Info
Lot Numbers: CB036637, CB036683, CB036731, CB036778, CB036817 CB036903, CB036909, CB036977, CB037009, CB037057 CB037093, CB037114, CB037292, CB037382,
Root Cause
Process control
Action Taken
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.