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FLEXIBLE SCREWDRIVER, BONE AWL & DRILL (2015-11-23)
- Starting date:
- November 23, 2015
- 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-56294
Affected Products
- FLEXIBLE SCREWDRIVER SJ706R
- FLEXIBLE BONE AWL
- FLEXIBLE DRILL
Reason
The mechanical strength of the flexible shaft does not reliably meet the requirements of surgery. This leads to forced brittle fracture under bending loads causing fragments to be left behind.
Affected products
A. FLEXIBLE SCREWDRIVER SJ706R
Lot or serial number
All lots.
Model or catalog number
SJ706R
Companies
- Manufacturer
-
Aesculap AG & Co. KG
AESCULAP PLATZ
TUTTLINGEN
78532
GERMANY
B. FLEXIBLE BONE AWL
Lot or serial number
All lots.
Model or catalog number
SJ607R
Companies
- Manufacturer
-
Aesculap AG & Co. KG
AESCULAP PLATZ
TUTTLINGEN
78532
GERMANY
C. FLEXIBLE DRILL
Lot or serial number
All lots.
Model or catalog number
SJ723R
Companies
- Manufacturer
-
Aesculap AG & Co. KG
AESCULAP PLATZ
TUTTLINGEN
78532
GERMANY