Class 2 Device Recall prodisc

• Date Initiated by Firm: July 18, 2024
• Date Posted: September 24, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3212-2024
• Recall Event ID: 95164
• PMA Number: P070001S019
• Product Classification: Prosthesis, intervertebral disc - Product Code MJO
• Product: prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
• Code Information: UDI-DI 00843193113856; Lot 2024-0482
• Recalling Firm/ Manufacturer: Centinel Spine, Inc.; 900 Airport Rd Ste 3b; West Chester PA 19380-3416
• For Additional Information Contact: Jessica Staub ; 484-887-8803
• Manufacturer Reason for Recall: During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
• FDA Determined Cause: Process control
• Action: Customers were contacted via telephone beginning 7/18/24. The Centinel Quality team has identified a potential nonconformance on three specific lots in the prodisc c product family. We are requesting the return of the inventory that is assigned to you. We will provide replacement inventory proactively to support the business. Thank you for your support. In addition, an URGENT - MEDICAL DEVICE Recall Instructions for PRODISC C IMPLANTS notification letter was sent to the distributor. Required Action: Please retrieve the identified devices and return the affected devices to Centinel Spine Depth of Recall: This recall should be carried out to the hospital level, including Distributors and Consigned locations Please acknowledge that you have read the email and enable the Return Receipt. This is necessary to ensure traceability as part of the recall process. If you have any questions, please contact Jessica Staub 484.887.8803.
• Quantity in Commerce: 12 units
• Distribution: US Nationwide distribution.
• 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