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U.S. Department of Health and Human Services

Class 2 Device Recall Articulated Driver

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 Class 2 Device Recall Articulated Driversee related information
Date Initiated by FirmMay 30, 2013
Date PostedJuly 31, 2013
Recall Status1 Terminated 3 on September 19, 2013
Recall NumberZ-1832-2013
Recall Event ID 65568
Product Classification Driver, surgical, pin - Product Code GFC
ProductExactech 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 FL 32653-1630
For Additional Information ContactKaya 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		Under Investigation by firm
ActionExactech 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 Commerce57
DistributionUS Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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