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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening. Part number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466 Class II It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. 18 Z-0905-2013
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening. Part number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336. Class II It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. 24 Z-0904-2013
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening. Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090. Class II It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. 2 Z-0903-2013
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