Recall Z-0202-2015— Medacta Usa
Class II · Terminated
Class II FDA medical device recall by Medacta Usa, initiated 2014-09-22, terminated 2015-05-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162..
- Recalling firm
- Medacta Usa
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-22
- Terminated
- 2015-05-07
- Firm location
- Chicago, IL, United States
Product description
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.
Reason for recall
Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
Data sourced from openFDA. This site is unofficial and independent of the FDA.