NuVasive recalls Simplify Disc models with incorrect UDI barcodes that could lead to selecting the wrong disc size during surgery. Affected units have specific part numbers and lot codes. Consumers should contact NuVasive for details.
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.
NuVasive is recalling certain Simplify Disc spinal implants because their unique device identifiers have incorrect barcodes that might cause surgeons to select the wrong disc size during surgery. This could lead to improper spinal fusion and complications.
The barcodes on these discs contain the wrong Global Trade Item Number (GTIN) when scanned, which could cause the wrong disc size to be selected during surgery. This might lead to improper spinal fusion and potential complications.
Surgical patients who received one of the recalled Simplify Disc models during spinal surgery are most at risk. The recall applies to specific part numbers and lot codes used in the U.S. and Canada.
Check if your disc has part numbers like SM-5, SM-6, MD-4, MD-5, MD-6, LG-5, or LG-6 with specific lot codes listed in the recall notice. The affected units were sold in the U.S. and Canada between 2019 and 2023.
Identify your disc's part number and lot code to see if it matches the recalled list.
Reach out to NuVasive directly for guidance on whether your disc is affected and next steps.
The barcodes on these discs contain incorrect Global Trade Item Numbers that could lead to selecting the wrong disc size during surgery.
Simplify Disc models with part numbers SM-5, SM-6, MD-4, MD-5, MD-6, LG-5, LG-5L, LG-6, and LG-6L, along with specific lot codes.
Contact NuVasive directly to determine if your disc is affected and follow their instructions.
We’ve drafted a message you can send NuVasive to request your refund or repair — edit it as you like.
Subject: Recall Z-1453-2022 — NuVasive NuVasive Hello, I own a NuVasive that is covered by recall Z-1453-2022 from NuVasive. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
