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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 Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
Recall Number Z-0932-2013
Classification Class II
Code Info Part Number: 0609-2809-06, Lot: 39AQ
Product Distributed Qty 3 units
Reason For Recall Implants were incorrectly laser marked as 23mm instead of 28mm.

Event Detail

Event Id 62993
Product Type Devices
Status Ongoing
Recalling Firm Spine Smith Partners LP
City Austin
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in Texas.