Recall Z-1832-2013
Exactech, Inc. · initiated May 30, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot #: 52667001 Catalog #: 181-00-04
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1832-2013
- Initiated
- May 30, 2013
- Posted by FDA
- July 31, 2013
- Terminated
- September 19, 2013
- Product code
- GFC – Driver, Surgical, Pin
- Quantity
- 57
- Distribution
- US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX
- Recalling firm
- Exactech, Inc., Gainesville, FL