Z-2050-2026 Class II Ongoing
FDA device recall Z-2050-2026 was initiated by Centinel Spine, Inc. on March 20, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 30 units.
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