Device 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.
Z-1832-2013
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 65568
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57
- Official record key
device-enforcement:Z-1832-2013
Official wording
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.
Code information: Lot #: 52667001 Catalog #: 181-00-04
Distribution pattern: US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX
Derived failure modes
-
Unknown
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.