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U.S. Department of Health and Human Services

Class 2 Device Recall Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM

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 Class 2 Device Recall Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MMsee related information
Date Initiated by FirmMarch 20, 2026
Date PostedMay 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2050-2026
Recall Event ID 98721
PMA NumberP070001 P070001S019 P070001S025 
Product Classification Prosthesis, intervertebral disc - Product Code MJO
ProductProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Code Information Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026
FEI Number 3007494564
Recalling Firm/
Manufacturer		 Centinel Spine, Inc.
900 Airport Rd Ste 3b
West Chester PA 19380-3416
For Additional Information ContactJim Kuras
484-887-8873
Manufacturer 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.
FDA Determined
Cause 2		Labeling mix-ups
ActionCentinel 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.
Quantity in Commerce30 units
DistributionUS Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MJO
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