NuVasive Simplify Disc UDI Barcode Contains Incorrect Size Information
NuVasive Simplify Disc cervical implants have UDI barcodes with incorrect Global Trade Item Numbers that may cause selection of the wrong device size during implant surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm medical device where incorrect product identification could affect surgical outcomes. No illnesses or injuries have been reported as a result of this labeling error, which limits the severity to Score 3 per the rubric.
Plain-English summary
NuVasive Inc has issued a recall of Simplify Disc cervical artificial disc implants due to incorrect Global Trade Item Number (GTIN) information on the device identification barcodes. The UDI barcodes, when scanned, display the wrong GTIN, and the human-readable text on the Patient Label may also be incorrect. This labeling error could lead to surgical staff selecting an incorrectly sized disc during implantation.
The recall affects 1,963 units distributed across multiple U.S. states (California, Washington, Texas, Indiana, Missouri, Michigan, Florida, Virginia, and Oregon) and several international locations. Multiple product sizes and heights are involved, including Simplify Disc Sizes 1, 2, and 3 with various height configurations.
Patients who have had a Simplify Disc implanted should not discontinue or alter their medical care. Healthcare providers should verify that the correct device size was implanted and contact NuVasive if there are concerns about the device in place.
The recalled product
- 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…
- Manufacturer
- NuVasive Inc
- Category
- Medical Device — Spinal implant
- Affected units
- 1,963
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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