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 D
Check against the official notice below — it lists the full affected range.
NuVasive Inc. is recalling 1,963 Simplify cervical artificial discs distributed in the United States (California, Washington, Texas, Indiana, Missouri, Michigan, Florida, Virginia, and Oregon) and internationally (Delaware, New Zealand, Singapore, and United Kingdom). The recalled units have barcode labeling errors where the Unique Device Identifier (UDI) barcodes contain incorrect Global Trade Item Numbers (GTINs) on the Patient Label. When scanned, these barcodes may display the wrong GTIN, and the human-readable text may also be incorrect, creating a risk that an incorrectly sized disc unit could be selected during a procedure.
The recall affects multiple disc sizes and heights across various lot codes, with specific model numbers and lot information provided for healthcare facilities and patients to identify affected units. The source record does not specify a remedy for consumers who may have received or been implanted with an affected device.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US: CA, WA, TX, IN, MO, MI, FL, VA, OR. OUS: DE, NZ, SG, UK Quantity: 1,963 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.