NuVasive Inc: Medical Device Recall in 2022 - (Recall #: Z-1453-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 20, 2022

Date Posted: August 3, 2022

Recall Number: Z-1453-2022

Event ID: 90500

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.

Status: Ongoing

Product Quantity: 1,963

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated