Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use

FDA device recall Z-1832-2013 · posted 2013-07-31 · Terminated

Recall details

Recalling firm

Exactech, Inc.

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.

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

GFC

Quantity affected

57

Distribution

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

Date initiated

2013-05-30

Date posted

2013-07-31

Date terminated

2013-09-19

Location

Gainesville, FL