Riverpoint Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
47
510(k) Clearances
38
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0518-2024Class IIIconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm AOctober 25, 2023
Z-0949-2021Class IICovidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 4December 9, 2020
Z-0034-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CVAugust 3, 2020
Z-0036-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 2August 3, 2020
Z-0037-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDIAugust 3, 2020
Z-0043-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV22August 3, 2020
Z-0030-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product Number: SAugust 3, 2020
Z-0023-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting, Product NAugust 3, 2020
Z-0029-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product NumbeAugust 3, 2020
Z-0032-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: August 3, 2020
Z-0019-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SAugust 3, 2020
Z-0012-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product NumAugust 3, 2020
Z-0047-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDIAugust 3, 2020
Z-0044-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDAugust 3, 2020
Z-0031-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, PrAugust 3, 2020
Z-0049-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting SV2298, UDAugust 3, 2020
Z-0016-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product NumAugust 3, 2020
Z-0018-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper, Product NuAugust 3, 2020
Z-0010-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product NumAugust 3, 2020
Z-0045-2021Class IIVelosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 208August 3, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K253693Strut Suture; No-Tie ButtonMarch 11, 2026
K253695LigaMendFebruary 27, 2026
K253024ProZip Knotless ImplantOctober 16, 2025
K252201HS FiberAugust 13, 2025
K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorJuly 30, 2025
K243988RootMend MRRMarch 20, 2025
K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructNovember 26, 2024
K243323Iconix Knotless AnchorNovember 19, 2024
K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorOctober 29, 2024
K241282RibFix Titan™ Fixation SystemAugust 19, 2024
K241577Iconix® AnchorJuly 3, 2024
K240719OC JuggerKnot Soft AnchorApril 11, 2024
K240213Iconix Knotless AnchorFebruary 23, 2024
K240194ProCinch, QuadCinchFebruary 21, 2024
K231163HS Fiber SuturesJanuary 5, 2024
K233552IDEAL ZiploopNovember 30, 2023
K233468Iconix AnchorNovember 14, 2023
K232411JuggerKnot Soft Anchor OCOctober 6, 2023
K231078All-Suture AnchorOctober 5, 2023
K231278Knotless Suture AnchorAugust 1, 2023