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Artas Disposable Kit (2013-10-14)
- Starting date:
- October 14, 2013
- Posting date:
- December 17, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37211
Recalled products
A. Artas Disposable Kit
Reason
There is a discoloration on the tensioner pins that was observed prior to performing the Artas procedure. This discoloration has been identified as a compound of iron and chlorine and found to be a remnant of the cleaning process used on the stainless steel (SS303) tensioner pins by the pin manufacturer. Action has been taken to ensure that replacement product uses pins that have been properly cleaned and all potentially affected product in the field are to be returned and replaced.
Affected products
A. Artas Disposable Kit
Lot or serial number
- 12490
Model or catalog number
- FP-45384
- FP-45616
Companies
- Manufacturer
-
Restoration Robotics
128 Baytech Drive
San Jose
95134
California
UNITED STATES