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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
Recall Number Z-0904-2013
Classification Class II
Code Info Part number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.
Product Distributed Qty 24
Reason For Recall It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

Event Detail

Event Id 64195
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 Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.