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FDA Medical Device Recalls (openFDA)

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.

Recall number
Z-2744-2011
Recalling firm
Cambridge Endoscopic Devices, Incorporated
Product
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.
Status
Terminated
Initiated
2011-05-20
Posted
2011-07-06
Terminated
2012-07-24
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.
Lot, serial or model codes
Lot Numbers: CB036695, CB036727, CB036932, CB036708, CB036931 CB037433
510(k) numbers
["K061425"]
PMA numbers
not on file
Product code
GEI
Firm FEI
3005256487
Firm city
Framingham
Firm state
MA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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