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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Recall Number Z-0378-2013
Classification Class II
Code Info Batch: JK2041, JK2146, JK2396, JK2397
Product Distributed Qty 240 units total
Reason For Recall The tulip portion of the screw assembly can disengage from the shank after implantation.

Event Detail

Event Id 52634
Product Type Devices
Status Terminated
Recalling Firm NuVasive Inc
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-01-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.