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U.S. Department of Health and Human Services

Class 2 Device Recall Articulated Driver

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 Class 2 Recall
Articulated Driver
see related information
Date Posted July 31, 2013
Recall Status1 Terminated on September 19, 2013
Recall Number Z-1832-2013
Recall Event ID 65568
Product Classification Driver, Surgical, Pin - Product Code GFC
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.
Code Information Lot #: 52667001 Catalog #: 181-00-04
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville, Florida 32653-1630
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Kaya Davis
800-392-2832
Manufacturer 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 2
OTHER/UNDETERMINED: Under Investigation by the 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 in Commerce 57
Distribution 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.
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