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FOOTSWITCH (ACCESSORY TO CUSA CLARITY SYSTEM) (2017-09-26)
- Starting date:
- September 26, 2017
- Posting date:
- October 13, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-64840
Affected products
FOOTSWITCH (ACCESSORY TO CUSA CLARITY SYSTEM)
Reason
Integra has identified a supplier manufacturing issue, through a complaint investigation, involving certain lots of the footswitch that is packaged with the CUSA Clarity Console (C7000). The faulty footswitch may result in unintended ultrasonic fragmentation activation.
Affected products
FOOTSWITCH (ACCESSORY TO CUSA CLARITY SYSTEM)
Lot or serial number
- Lot #1885744
- Lot #1923802
- Lot #1985221
- Lot #2057996
- Lot #2109587
- Lot #2118507
Model or catalog number
C7002
Companies
- Manufacturer
-
Integra Lifesciences (Ireland) Ltd.
Ida Business and Technology Park
Sragh, Tullamore, Offaly
IRELAND