Recall Z-1832-2013— Exactech, Inc.
Class II · Terminated
Class II FDA medical device recall by Exactech, Inc., initiated 2013-05-30, terminated 2013-09-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.. Reason: When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-30
- Terminated
- 2013-09-19
- Firm location
- Gainesville, FL, United States
Product description
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Reason for recall
When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.
Data sourced from openFDA. This site is unofficial and independent of the FDA.