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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

Product Description Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
Recall Number Z-1456-2014
Classification Class II
Code Info Part no. 305.840, with lot nos.: 5680577, 5701123, 5713215, 5763130, 5783316, 5787131, 5828296, 6124867, 6136125, 6150803, 6167974, 6167975, 6218358, 6222322, 6258395, 6365430, 6365431, 6390225, 6425013, 6456634, 6487035, 6556704, 6624880, 6650136, 6668870, 6743859, 6844968, 6926708, 6983799, 7008819, 7038706, 7221395, 7138319.
Product Distributed Qty 20081
Reason For Recall The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.

Event Detail

Event Id 67499
Product Type Devices
Status Ongoing
Recalling Firm Synthes, Inc.
City West Chester
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution
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