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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Event Detail

Event ID 66530
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 2013-08-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion. Part J5957AC (old), and Part J5957F (new) Class II The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction. 374 Z-0429-2014