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6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

FDA Recall #Z-0375-2013 — Class II — January 5, 2009

Recall #Z-0375-2013 Date: January 5, 2009 Classification: Class II Status: Terminated

Product Description

6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

Reason for Recall

The tulip portion of the screw assembly can disengage from the shank after implantation.

Recalling Firm

NuVasive Inc — San Diego, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

240 units total

Distribution

Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.

Code Information

Batch: 2008400621, JK2039, JK2141, JK2191, JK2177, JK2178, JK2179, JK2181, JK2182, JK2183, JK2141, JK2181

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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