Home / Recalls / Centinel Spine, Inc. / Z-2050-2026

Z-2050-2026 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
May 13, 2026
Initiation Date
March 20, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 units

Product Description

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

Reason for Recall

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

Distribution Pattern

US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.

Code Information

Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026

Other recalls by Centinel Spine, Inc.

  • Z-2051-2026 Class II — Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervic (March 20, 2026)
  • Z-1426-2026 Class II — Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 So (December 31, 2025)
  • Z-3212-2024 Class II — prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Nu (July 18, 2024)
  • 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)