Centinel Spine, Inc.
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Centinel Spine, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-25FDA-DeviceClass IIBrand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Products were mislabeled as the 6mm product but included the 5 mm product.
- 2024-10-02FDA-DeviceClass IIprodisc C SK, Total cervical disc replacement, 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.
- 2024-10-02FDA-DeviceClass IIprodisc 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.
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