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TI SINGLE VECTOR DISTRACTOR (2016-06-09)
- Starting date:
- June 9, 2016
- Posting date:
- June 24, 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-59032
Affected products
- TI SINGLE VECTOR DISTRACTOR BODY WITH RIGHT FOOT
- TI SINGLE VECTOR DISTRACTOR BODY WITH LEFT FOOT
- TI SINGLE VECTOR DISTRACTOR PROXIMAL FOOT/RIGHT
- TI SINGLE VECTOR DISTRACTOR PROXIMAL FOOT/LEFT
Reason
The fastener on the mandible distractor may become prematurely separated from the proximal foot plate.
Affected products
A. TI SINGLE VECTOR DISTRACTOR BODY WITH RIGHT FOOT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 487.962
- 487.964
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES
B. TI SINGLE VECTOR DISTRACTOR BODY WITH LEFT FOOT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 487.963
- 487.965
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES
C. TI SINGLE VECTOR DISTRACTOR PROXIMAL FOOT/RIGHT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 487.974
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES
D. TI SINGLE VECTOR DISTRACTOR PROXIMAL FOOT/LEFT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 487.975
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES