Recall Z-1832-2013 ยท GFC Driver, Surgical, Pin
Exactech, Inc.
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
| Date | Jul 31, 2013 (initiated May 30, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Exactech sent a" Important Product Recall Notice" dated June 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to Immediately cease distribution or use of the products. Extend this information to your accounts that may have this product in their possession. Verify if you have any of the subject ARTICULATE DRIVER (catalog number 181-00-04) in the specified lots. FAx back the attached form. Further questions please call 1-800-392-2832. |
| Quantity | 57 |
| Distribution | US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.