Z-0518-2024Class II

Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with...

Name: Z-0518-2024 Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with...
Creator: Riverpoint Medical, LLC
Published: 2023-10-25
License: https://open.fda.gov/license/

Riverpoint Medical, LLC / initiated 2023-10-25 / Open, Classified / root cause: design

FDA source

Riverpoint Medical, LLC began a recall of 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... on 2023-10-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0518-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-25
Posted: 2023-12-08
Recalling firm: Riverpoint Medical, LLC
Product: 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.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 10/25/2023, the firm emailed its customer an "URGENT: MEDICAL DEVICE CORRECTION" Letter informing them that the Iconix Knotless Anchor 's Instruction for Use is insufficient to prevent/avoid inserter buckling and insertion failure. The customers were instructed to do the following: - Immediately examine your inventory. If you have the part numbers listed above, notify end user with additional instructions for use. Users may continue to use field inventory once the acknowledgement letter has been completed. - Complete and return the response form as soon as possible to [email protected]. Mark the return shipments with RGA#2081- PDX. - Provide field correction information to any customers to whom you may have distributed or forwarded affected products. You may include a copy of the recall notice with your customer notification. - A copy of the notification letter and of IFU may be posted on or near the affected products, so users are aware of the additional instructions.
Quantity in commerce: 999 devices
Distribution: U.S. Nationwide distribution in the state of CA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0518-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0518-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-08

Product code MBI

K231278Class IIKnotless Suture AnchorRiverpoint Medical, LLC / cleared 2023-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)