prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5

FDA device recall Z-3212-2024 · posted 2024-09-24 · Open, Classified

Recall details

Recalling firm

Centinel Spine, Inc.

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

MJO

Quantity affected

12 units

Distribution

US Nationwide distribution.

Date initiated

2024-07-18

Date posted

2024-09-24

Location

West Chester, PA