Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Recall
- Recall Number
- Z-2050-2026
- Event Number
- 98721
- Firm
- Centinel Spine, Inc.
- FEI Number
- 3007494564
- Product Code
- MJO
- Status
- Open, Classified
- Root Cause
- Labeling mix-ups
- Initiated
- March 20, 2026
- Posted
- May 1, 2026
- Address
- 900 Airport Rd, Ste 3b, West Chester, PA, 19380-3416
Description
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
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.
Centinel Spine notified distributors on about 03/20/2026 via telephone calls and emailed letter. Surgeons were sent letters via FedEx on 03/24/2026 and by email on 03/25/2026 & 03/26/2026. Distributors were instructed to identify any affected units on hand, provide photographs documenting such, and arrange for the return of all affected units. Additionally, distributors have been instructed to diligently check prodisc C SK inventory prior to any scheduled surgery to ensure that the recalled lot numbers are not available for implantation. This includes both consignment and loaner inventory. Acknowledgment of the letter has been requested with return envelopes provided. For surgeons, they were instructed to monitor any patient(s) that have received the recalled device for any unexpected device-related symptoms throughout the regularly scheduled check-in procedures. Centinel Spine intends to remove from the market all remaining implants within the lots effected by this recall and issue a replacement product with corrected labeling for any remaining products that are subject to this recall.
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
30 units