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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
Recall Number Z-0938-2013
Classification Class II
Code Info Lot Number 7542279
Product Distributed Qty 18
Reason For Recall Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.

Event Detail

Event Id 64173
Product Type Devices
Status Ongoing
Recalling Firm Synthes USA HQ, Inc.
City West Chester
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.