Centinel Spine, Inc. recalls Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replace…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Lot / code information
- Model
- PDSXL5
- UDI
- 00843193113979
- Lot #
- 2026-0026
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2050-2026
- FDA device classification · MJOOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Centinel Spine, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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