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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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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
Distribution Pattern Distributed in Texas.

Product Detail

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