medical Class II Updated 2022-08-03

NuVasive Inc recalls Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simpli

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, WA, TX, IN, MO, MI, FL, VA, OR, DE
Lot/Code Info: 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
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