Home / Recalls / Centinel Spine, Inc. / Z-3212-2024

Z-3212-2024 Class II Ongoing

Recalled by Centinel Spine, Inc. — West Chester, PA

Recall Details

Product Type
Devices
Report Date
October 2, 2024
Initiation Date
July 18, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 units

Product Description

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

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.

Distribution Pattern

US Nationwide distribution.

Code Information

UDI-DI 00843193113856; Lot 2024-0482

Other recalls by Centinel Spine, Inc.

  • Z-1426-2026 Class II — Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 So (December 31, 2025)
  • Z-3213-2024 Class II — prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 (July 18, 2024)
  • Z-1406-2021 Class II — Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skelet (March 5, 2021)