Device recall: Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S…
Class II FDA enforcement event 93390. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Riverpoint Medical, LLC started this device recall on 25 Oct 2023. The firm address in the FDA record is in Portland, OR. FDA put the recall in Class II. FDA event 93390 has 1 product record. The first FDA enforcement report date is 20 Dec 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
U.S. Nationwide distribution in the state of CA.
Recalling firm
Riverpoint Medical, LLC, Portland, OR.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0518-2024 | Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. | 999 devices | Class II | Ongoing | 20 Dec 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Dec 2020 | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 1 | Device | Class II | 1 |
| 3 Aug 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 208 | Device | Class II | 40 |
| 8 Feb 2019 | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical | Device | Class II | 1 |
| 9 Jan 2018 | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used | Device | Class III | 1 |
| 5 Aug 2016 | Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. | Device | Class II | 2 |
| 13 Dec 2012 | Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0518-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93390. https://recallregister.com/fda/ii/93390/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
U.S. Nationwide distribution in the state of CA.
- What quantity of product is in FDA event 93390?
- The FDA record gives this quantity:
999 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.