||July 31, 2013
||Terminated on September 19, 2013
|Recall Event ID
Driver, surgical, pin -
||Exactech Articulated Driver
A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
||Lot #: 52667001
Catalog #: 181-00-04
2320 NW 66th Ct
|For Additional Information Contact
|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.
|Under Investigation by firm
||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 in Commerce
||US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.