Class 2 Device Recall Prodisc C

• Date Initiated by Firm: March 05, 2021
• Create Date: April 09, 2021
• Recall Status: Terminated on August 02, 2021
• Recall Number: Z-1406-2021
• Recall Event ID: 87530
• PMA Number: P070001
• Product Classification: Prosthesis, intervertebral disc - Product Code MJO
• Product: Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
• Code Information: UDI (01)00843193112842(17)241231(10)2020-0600 Lot number: 2020-0600
• FEI Number: 3007494564
• Recalling Firm/ Manufacturer: Centinel Spine, Inc.; 900 Airport Rd Ste 3b; West Chester PA 19380-3416
• For Additional Information Contact: James M. Kuras; 484-887-8873
• Manufacturer Reason for Recall: Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.
• FDA Determined Cause: Employee error
• Action: In March 2021, Centinel issued an Urgent Medical Device Recall notice to customers and distributers via letter and email notifying them the "UP" etching on the superior plate is missing. The "UP" is used to signify that the implant should be inserted into the intradiscal space with "UP" towards the head or in the cephalic position. In those devices with "UP" missing, there is a risk that the device could be placed upside-down within the intradiscal space.
• Quantity in Commerce: 49 devices
• Distribution: US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MJO