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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65568
Product Type Devices
Status Ongoing
Recalling Firm Exactech, Inc.
City Gainesville
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-30
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Lot #: 52667001 Catalog #: 181-00-04 Class II 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. 57 Z-1832-2013