Home / Recalls / NuVasive Inc / Z-1453-2022

Z-1453-2022 Class II Ongoing

Recalled by NuVasive Inc — San Diego, CA

FDA device recall Z-1453-2022 was initiated by NuVasive Inc on June 20, 2022 and is designated Class II. Reason for recall: Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human r… The recall status is ongoing. Affected quantity: 1,963.

Recall Details

Product Type
Devices
Report Date
August 3, 2022
Initiation Date
June 20, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,963

Product Description

Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc Size 3, Ht 5/LG-5; Simplify Disc Size 3, Ht 5, 5/LG-5L; Simplify Disc Size 3, Ht 6/LG-6; Simplify Disc Size 3, Ht 6, 5/LG-6L

Reason for Recall

Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.

Distribution Pattern

US: CA, WA, TX, IN, MO, MI, FL, VA, OR. OUS: DE, NZ, SG, UK

Code Information

Part/Correct GTIN (DI)/Lot: SM-5/843285100023/W79256, W82070, W80144; SM-6/843285100047/W80703, W81624, W80701, W81132, W81133, W81633, W81625, W81611, W81828, W81971, W82544, W82543, W81034, W81975, W81580, W81612, W81621, W81131, W81613, W80909, W81623, W81634, W79466, W81033, W81134, W81600, W79259; MD-5/843285100061/W81136, W81135, W80704, W80700; MD-5L/843285100078/W80707, W80706; MD-6/843285100085/W80911, W81642, W81643, W82545, W82546; MD-6L/843285100092/W81822; LG-5/843285100108/W81138, W81141, W79465, W81994, W81142, W81626, W81143, W79257; LG-5L/843285100115/W79258, W80146, W80915, W82548; LG-6/843285100122/W82547; LG-6L/843285100139/W81827

Other recalls by NuVasive Inc

  • Z-0738-2023 Class II — X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System use (November 10, 2022)
  • Z-1052-2023 Class III — NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version (July 19, 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-0363-2013 Class II — 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0374-2013 Class II — 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0364-2013 Class II — 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0359-2013 Class II — 6.5mm x 50mm Cannulated 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-0377-2013 Class II — 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)

FDA data resources