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GoDirect Implants (2016-03-04)
- Starting date:
- March 4, 2016
- Posting date:
- March 17, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57578
Affected Products
A. GoDirect Indirect Implant 3.0MMD
B. GoDirect Indirect Implant 3.7MMD
C. GoDirect Indirect Implant 4.7MMD
Reason
Through an internal evaluation process a field correction is actioned for some consignees who did not receive the correct tool to drive the implant to bone level. Data indicates the possibility of occurrence is rare (0.59%).
Affected products
A. GoDirect Indirect Implant 3.0MMD
Lot or serial number
39506
40542
44661
51249
54274
54275
60158
Model or catalog number
423011
423013
433010
Companies
- Manufacturer
-
Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks
91362
California
UNITED STATES
B. GoDirect Indirect Implant 3.7MMD
Lot or serial number
40394
Model or catalog number
433710
Companies
- Manufacturer
-
Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks
91362
California
UNITED STATES
C. GoDirect Indirect Implant 4.7MMD
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
424708
424710
424713
Companies
- Manufacturer
-
Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks
91362
California
UNITED STATES