Device product
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Z-1514-2018
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 79698
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31
- Official record key
device-enforcement:Z-1514-2018
Official wording
Reason: There is a potential for the connection screw of the stem extractor to break.
Code information: 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949
Distribution pattern: Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.
Derived failure modes
-
Unknown
There is a potential for the connection screw of the stem extractor to break.