FDAOctober 5, 2016device
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System cons...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
What to do
FDA enforcement status: Terminated
Brands named
alphatec spinealphatec
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- 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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