—#119601

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.

FDA product code: GFC — Driver, Surgical, Pin
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot #: 52667001 Catalog #: 181-00-04

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX

Timeline

Recall initiated: 2013-05-30
Posted by FDA: 2013-07-31
Terminated: 2013-09-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119601. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.