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MIDAS REX MICROSAWS (2016-05-18)
- Starting date:
- May 18, 2016
- Posting date:
- June 30, 2016
- 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-59110
Affected products
A. MIDAS REX MICROSAWS
Reason
Medtronic powered surgical solutions testing of the sagittal saw rocker arm seal identified a potential for leakage of fluid into the motor during use. There have been no reports from the field of leakage into or out of the sagittal saw. In assessing the risk of this potential failure mode, it was determined that the gravity sterilization cycle included in the IPC user manual may not be adequate to ensure sterility of the saws if fluid ingress occurs beyond the rocker housing seal.
Affected products
A. MIDAS REX MICROSAWS
Lot or serial number
P06274726
P06279710
Model or catalog number
ES300
ES310
Companies
- Manufacturer
-
Medtronic Powered Surgical Solutions
4620 NORTH BEACH STREET
Fort Worth
76137
Texas
UNITED STATES