Device product
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
Z-0202-2015
Product summary
- Firm
- Medacta Usa
- Event
- Event 69493
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 rod (US); 145 rods (global)
- Official record key
device-enforcement:Z-0202-2015
Official wording
Reason: Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
Code information: Model Number: 02.07.10.0162
Distribution pattern: Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
Derived failure modes
-
Unknown
Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.