FDAJuly 18, 2024device
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
centinel spinecentinel
UPCs
00843193113856
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small, 13 Degree 10mm X 6mm, ...2026-04-23
- FDAProdisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.2026-03-20
- FDAProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.2026-03-20
- FDAATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use i...2026-01-02
- FDAATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use i...2026-01-02
- FDABrand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No2025-12-31
- FDATOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.2025-07-16
- FDAMonterey AL Implant Inserter; 10/12mm; Catalog 48019100.2025-02-28
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