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U.S. Department of Health and Human Services

Class 2 Device Recall Simplify Cervical Artificial Disc

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  Class 2 Device Recall Simplify Cervical Artificial Disc see related information
Date Initiated by Firm June 20, 2022
Create Date July 22, 2022
Recall Status1 Open3, Classified
Recall Number Z-1453-2022
Recall Event ID 90500
PMA Number P200022 
Product Classification Prosthesis, intervertebral disc - Product Code MJO
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
Code Information 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
Recalling Firm/
Manufacturer		 NuVasive Inc
7475 Lusk Blvd
San Diego CA 92121-5707
For Additional Information Contact
858-736-0318
Manufacturer 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.
FDA Determined
Cause 2		 Labeling Change Control
Action On 06/20/22, Field Safety notices were delivered in person, emailed, or mailed to hospital and distributor consignees who were informed of the following: 1) Complete and return the consignee confirmation form. 2) Return of affected devices is not required. However, if you would like these items exchanged, please contact your firm representative to request a Return Material Authorization number (RMA). 3) This recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Customers with questions, complaints, or who want to report adverse effects can contact the firm at complaints@nuvasive.com
Quantity in Commerce 1,963
Distribution US: CA, WA, TX, IN, MO, MI, FL, VA, OR. OUS: DE, NZ, SG, UK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MJO and Original Applicant = NuVasive, Inc.
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