Centinel Spine, Inc.: Medical Device Recall in 2024 - (Recall #: Z-3213-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 18, 2024

Date Posted: October 2, 2024

Recall Number: Z-3213-2024

Event ID: 95164

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.

Status: Ongoing

Product Quantity: 6 units

Code Information:

Lot Code: UDI-DI 00843193113856; Lot 2024-0482

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated