Home / Recalls / NuVasive Inc / Z-0375-2013

Z-0375-2013 Class II Terminated

Recalled by NuVasive Inc — San Diego, CA

Recall Details

Product Type
Devices
Report Date
November 28, 2012
Initiation Date
January 5, 2009
Termination Date
November 19, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
240 units total

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.

Distribution Pattern

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

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  • Z-1453-2022 Class II — Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6 (June 20, 2022)
  • Z-2684-2020 Class II — Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 008875 (June 10, 2020)
  • Z-1898-2020 Class II — NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usa (February 13, 2020)
  • Z-0362-2013 Class II — 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0370-2013 Class II — 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0355-2013 Class II — 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0372-2013 Class II — 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0363-2013 Class II — 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)