CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report

Iconix Knotless Anchor with XBraid S (Blue/Black) recalled

Riverpoint Medical is recalling Iconix Knotless Anchor with XBraid S (Blue/Black), distributed nationwide in the US. The recall was initiated on 25 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 3911-7 14-520 UDI-DI Code: 00840277402172 Lot Number: 23080433 Product Code: 3911-7 14-521 UDI-DI Code: 00840277402189 Lot Number: 23081617

Quantity recalled999 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0518-2024
FDA event ID: 93390
Recalling firm: Riverpoint Medical, Portland, OR
Classification: Class II
Status: Ongoing
Recall initiated: 25 Oct 2023
FDA classified: 8 Dec 2023
Reported: 20 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

25 Oct 2023	Recall initiated by company
8 Dec 2023	Classified by FDA	+44 days
20 Dec 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

U.S. Nationwide distribution in the state of CA.

Nationwide California

Questions about this recall

Why was it recalled?

Which lots are affected?

Product Code: 3911-7 14-520 UDI-DI Code: 00840277402172 Lot Number: 23080433 Product Code: 3911-7 14-521 UDI-DI Code: 00840277402189 Lot Number: 23081617

Where was it sold?

U.S. Nationwide distribution in the state of CA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Riverpoint Medical

All 47

Reported	Class	Recall	Company	Reason	Where
10 Feb 2021Device	CLASS II	Covidien CV-9590 Velosorb Fast Braided Fast absorbable recalled	Riverpoint Medical	Device Malfunction	NJ
7 Oct 2020Device	CLASS II	Velosorb Fast Braided Absorbable Suture recalled by Riverpoint Medical	Riverpoint Medical	Sterility	Nationwide
7 Oct 2020Device	CLASS II	Velosorb Fast Braided Absorbable Suture recalled by Riverpoint Medical	Riverpoint Medical	Sterility	Nationwide
7 Oct 2020Device	CLASS II	Velosorb Fast Braided Absorbable Suture recalled by Riverpoint Medical	Riverpoint Medical	Sterility	Nationwide
7 Oct 2020Device	CLASS II	Velosorb Fast Braided Absorbable Suture recalled by Riverpoint Medical	Riverpoint Medical	Sterility	Nationwide

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