Description/Part: Simplify Disc Size 1 — Class II medical device recall Z-1453-2022
Ongoing recall by NuVasive Inc, reported 2022-08-03, distributed in CA, FL, IN, MI, MO, OR, TX, VA…. Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Numbe
| Recall number | Z-1453-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NuVasive Inc, San Diego, CA, United States |
| Recall initiated | 2022-06-20 |
| Classified | 2022-07-22 |
| Reported by FDA | 2022-08-03 |
| Distributed | CA, FL, IN, MI, MO, OR, TX, VA, WA |
| Countries outside the US | GB |
| Quantity | 1,963 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00843285100023, 00843285100047, 00843285100061, 00843285100078, 00843285100085, 00843285100092, 00843285100108, 00843285100115, 00843285100122, 00843285100139 |
| Lot numbers | LG-5/843285100108/W81138, LG-5L/843285100115/W79258, LG-6/843285100122/W82547, LG-6L/843285100139/W81827, MD-5/843285100061/W81136, MD-5L/843285100078/W80707, MD-6/843285100085/W80911, MD-6L/843285100092/W81822, SM-5/843285100023/W79256, SM-6/843285100047/W80703, W79257, W79259, W79465, W79466, W80144, W80146, W80700, W80701, W80704, W80706, W80909, W80915, W81033, W81034, W81131, W81132, W81133, W81134, W81135, W81141, W81142, W81143, W81580, W81600, W81611, W81612, W81613, W81621, W81623, W81624 and 16 more |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1453-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.