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Health product recall

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

  1. TI SINGLE VECTOR DISTRACTOR BODY WITH RIGHT FOOT
  2. TI SINGLE VECTOR DISTRACTOR BODY WITH LEFT FOOT
  3. TI SINGLE VECTOR DISTRACTOR PROXIMAL FOOT/RIGHT
  4. 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