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APPLICATION INSTRUMENT FOR STERNAL ZIPFIX(2015-09-01)
- Starting date:
- September 1, 2015
- Posting date:
- September 24, 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-55028
Affected Products
A. APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
Reason
In the specified lots of the application instrument for Sternal Zipfix, the end cap may loosen, thus reducing the tension applied to the implant. Also, the end cap may detach, allowing the tensioning spring to also become detached, and making the instrument non-functional.
Affected products
A. APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
Lot or serial number
>10, contact mfg
Model or catalog number
03.501.080
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES