Centinel Spine recalls
3 official recalls and safety alerts involving Centinel Spine since 2024-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Centinel Spine or the relevant agency.
- 2026-05-13
USCentinel Spine, Inc. recalls 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.
FDA · DeviceCentinel Spine, Inc.US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.Official notice →- 2026-02-25
- US
Centinel Spine, Inc. recalls Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc…
Products were mislabeled as the 6mm product but included the 5 mm product.
FDA · DeviceCentinel Spine, Inc.US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.Official notice → - 2024-10-02
- US
Centinel Spine, Inc. recalls prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.