Riverpoint Medical, LLC
Medical device manufacturer in Portland, OR.
39510(k) clearances
0PMA approvals
47recalls
Device types
- MBI Fastener, Fixation, Nondegradable, Soft… 23
- GAT Suture, Nonabsorbable, Synthetic… 7
- KNW Instrument, Biopsy 1
- NEW Suture, Surgical, Absorbable, Polydioxanone 1
- KXK Source, Brachytherapy, Radionuclide 1
- GAM Suture, Absorbable, Synthetic, Polyglycolic… 1
- NBY Suture, Surgical, Nonabsorbable, Expanded… 1
- LZU Plug, Punctum 1
- GAR Suture, Nonabsorbable, Synthetic, Polyamide 1
- JDQ Cerclage, Fixation 1
- HRS Plate, Fixation, Bone 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262677 | Iconix Knotless TMBI · Special | 08/27/2026SE |
| K253693 | Strut Suture; No-Tie ButtonMBI · Traditional | 03/11/2026SE |
| K253695 | LigaMendMBI · Traditional | 02/27/2026SE |
| K253024 | ProZip Knotless ImplantGAT · Special | 10/16/2025SE |
| K252201 | HS FiberGAT · Special | 08/13/2025SE |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ AnchorMBI · Special | 07/30/2025SE |
| K243988 | RootMend MRRMBI · Traditional | 03/20/2025SE |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructMBI · Traditional | 11/26/2024SE |
| K243323 | Iconix Knotless AnchorMBI · Special | 11/19/2024SE |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorMBI · Special | 10/29/2024SE |
| K241282 | RibFix Titan Fixation SystemHRS · Traditional | 08/19/2024SE |
| K241577 | Iconix® AnchorMBI · Special | 07/03/2024SE |
| K240719 | OC JuggerKnot Soft AnchorMBI · Special | 04/11/2024SE |
| K240213 | Iconix Knotless AnchorMBI · Special | 02/23/2024SE |
| K240194 | ProCinch, QuadCinchMBI · Special | 02/21/2024SE |
| K231163 | HS Fiber SuturesGAT · Traditional | 01/05/2024SE |
| K233552 | IDEAL ZiploopMBI · Special | 11/30/2023SE |
| K233468 | Iconix AnchorMBI · Special | 11/14/2023SE |
| K232411 | JuggerKnot Soft Anchor OCMBI · Traditional | 10/06/2023SE |
| K231078 | All-Suture AnchorMBI · Traditional | 10/05/2023SE |
| K231278 | Knotless Suture AnchorMBI · Traditional | 08/01/2023SE |
| K220765 | HS Fiber CerclageJDQ · Traditional | 07/26/2023SE |
| K231128 | JuggerKnot Soft AnchorMBI · Special | 05/17/2023SE |
| K230212 | OrthoButton ALMBI · Special | 02/23/2023SE |
| K203740 | JuggerKnot Soft AnchorMBI · Traditional | 02/12/2021SE |
| K202399 | OrthoButton FLMBI · Special | 09/18/2020SE |
| K202242 | HS FiberGAT · Special | 09/10/2020SE |
| K190817 | HS FiberGAT · Special | 05/01/2019SE |
| K171060 | OrthoButton ALMBI · Special | 06/02/2017SE |
| K160655 | OrthoButton CLMBI · Traditional | 06/03/2016SE |
| K153307 | HS SutureTapeGAT · Special | 02/12/2016SE |
| K152795 | RiverLon (Nylon) SutureGAR · Special | 10/28/2015SE |
| K150288 | PDO Absorbable Punctum PlugLZU · Traditional | 08/28/2015SE |
| K140415 | MonotexNBY · Abbreviated | 03/26/2014SE |
| K120556 | Vilet Vilet QuickGAM · Abbreviated | 05/23/2012SE |
| K103449 | Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersKXK · Abbreviated | 02/25/2011SE |
| K100461 | PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutNEW · Abbreviated | 07/08/2010SE |
| K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…GAT · Abbreviated | 05/10/2010SE |
| K092059 | RP Cutting NeedleKNW · Traditional | 09/24/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0518-2024 Class II | Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless…Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures… | 10/25/2023Open, Classified |
| Z-0949-2021 Class II | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24…Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength.… | 12/09/2020Terminated |
| Z-0049-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0048-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0047-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0046-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0045-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0044-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0043-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0042-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0041-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0040-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0039-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0038-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0037-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0036-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0035-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0034-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0033-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0032-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0031-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0030-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0029-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0028-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0027-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0026-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0025-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0024-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0023-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0022-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0021-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0020-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-12, Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0019-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0018-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0017-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-24, Product…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0016-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0015-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0014-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0013-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0012-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0011-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0010-2021 Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting…The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site… | 08/03/2020Terminated |
| Z-0795-2020 Class II | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on…The integrity of the sterile grid packaging is potentially compromised. | 02/08/2019Terminated |
| Z-0777-2019 Class III | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The…Product is labeled with "CE", but is not yet approved in the European Union. | 01/09/2018Terminated |
| Z-2762-2016 Class II | Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part…Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or… | 08/05/2016Terminated |
| Z-2761-2016 Class II | Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon…Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent… | 08/05/2016Terminated |
| Z-0347-2014 Class II | Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET…Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is… | 12/13/2012Terminated |