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Vector TAS Kit and Vector Modular Driver (2011-11-30)
- Starting date:
- November 30, 2011
- Posting date:
- April 4, 2014
- 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-38647
Recalled Products
- Vector TAS Kit
- Vector TAS Modular Driver
Reason
Vector TAS Modular driver instructions for use specified incorrect sterilization temperatures in some no-English language sections. Specifically, an incorrect sterilization temperature of 130 degrees Celsius was speficied rather than the correct temperature of 132 degrees Celsius.
Affected products
A. Vector TAS Kit
Lot or serial number
All lots
Model or catalog number
- 601-0007
Companies
- Manufacturer
-
Ormco Corporation, also trading as SybronEndo
1332 South Lone Hill Ave.
Glendora
91740
California
UNITED STATES
B. Vector TAS Modular Driver
Lot or serial number
All lots
Model or catalog number
- 601-0010
Companies
- Manufacturer
-
Ormco Corporation, also trading as SybronEndo
1332 South Lone Hill Ave.
Glendora
91740
California
UNITED STATES