Reported Aug 3, 2022 · Ongoing
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;…
NuVasive Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NuVasive Inc · 7475 Lusk Blvd · San Diego, CA · 92121-5707
Is this the product you have?
11 of 11 products
| # | Product as published |
|---|---|
| 1 | Description/Part: Simplify Disc Size 1, Ht 5/SM-5 |
| 2 | Simplify Disc Size 1, Ht 6/SM-6 |
| 3 | Simplify Disc Size 2, Ht 4/MD-4 |
| 4 | Simplify Disc Size 2, Ht 5/MD-5 |
| 5 | Simplify Disc Size 2, Ht 5, 5/MD-5L |
| 6 | Simplify Disc Size 2, Ht 6/MD-6 |
| 7 | Simplify Disc Size 2, Ht 6, 5/MD-6L |
| 8 | Simplify Disc Size 3, Ht 5/LG-5 |
| 9 | Simplify Disc Size 3, Ht 5, 5/LG-5L |
| 10 | Simplify Disc Size 3, Ht 6/LG-6 |
| 11 | Simplify Disc Size 3, Ht 6, 5/LG-6L |
- Lot codes and dates
10 of 10 products
Products covered by this recall # Barcodes Product as published 1 843285100023Part/Correct GTIN (DI)/Lot: SM-5/843285100023/W79256, W82070, W80144 2 843285100047SM-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 3 843285100061MD-5/843285100061/W81136, W81135, W80704, W80700 4 843285100078MD-5L/843285100078/W80707, W80706 5 843285100085MD-6/843285100085/W80911, W81642, W81643, W82545, W82546 6 843285100092MD-6L/843285100092/W81822 7 843285100108LG-5/843285100108/W81138, W81141, W79465, W81994, W81142, W81626, W81143, W79257 8 843285100115LG-5L/843285100115/W79258, W80146, W80915, W82548 9 843285100122LG-6/843285100122/W82547 10 843285100139LG-6L/843285100139/W81827 - Amount recalled
- 1,963
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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