RecallRadar

FDA Device recall Z-1426-2026

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc r…

On 2026-02-25 the FDA classified a Class II recall of Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc r… by Centinel Spine, citing products were mislabeled as the 6mm product but included the 5 mm product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1426-2026
ClassificationClass II
Statusongoing
Initiated2025-12-31
Published2026-02-25
Last updated2026-09-13 11:58 UTC
CompanyCentinel Spine
DistributionUS

Product

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

Reason

Products were mislabeled as the 6mm product but included the 5 mm product.

Identifiers

code_infoModel Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1426-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.