Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cm Catalog Number: LA1101-
FDA device recall Z-2744-2011 · posted 2011-07-06 · Terminated
Recall details
- Recalling firm
- Cambridge Endoscopic Devices, Incorporated
- Reason for recall
- PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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, Switzerla
- Date initiated
- 2011-05-20
- Date posted
- 2011-07-06
- Date terminated
- 2012-07-24
- Location
- Framingham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01 (K061425) | Cambridge Endoscopic Devices | 2006-08-10 |