Centinel Spine, Inc.: Device Recall

Recall #Z-3213-2024 · 07/18/2024

Class II: Risk

Recall Details

Recall Number: Z-3213-2024
Classification: Class II
Product Type: Device
Recalling Firm: Centinel Spine, Inc.
Status: Ongoing
Date Initiated: 07/18/2024
Location: West Chester, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 units

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.

Product Description

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

Distribution Pattern

US Nationwide distribution.

Other Recalls by Centinel Spine, Inc.

Class II: Risk 07/18/2024

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.

View all recalls by Centinel Spine, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.