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Gap Endo-Exo Medullary Nail Driver
- Starting date:
- August 10, 2017
- Posting date:
- September 8, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-64448
Reason
It appears that breakage of the instrument occurs when bending, impaction or excessive torsinal forces are applied on the instrument. The recalled lot numbers were previously reworked and they appear to be more susceptible to breakage considering that residual stresses may have been generated during the rework.
Affected products
Gap Endo-Exo Medullary Nail Driver
Lot or serial number
- 110922-052
- 130102-010
Model or catalog number
GAP-NDR100
Companies
- Manufacturer
-
Pega Medical Inc.
111 autoroute Chomedey
Laval
H7W 5J8
Quebec
CANADA