Riverpoint Medical, LLC: 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.

Recall number

Z-0518-2024

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.

Status

Open, Classified

Initiated

2023-10-25

Posted

2023-12-08

Terminated

not on file

Reason

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

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 quality@rpmed.com. 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

999 devices

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K231278"]

PMA numbers

not on file

Product code

MBI

Firm FEI

3006981798

Firm city

Portland

Firm state

OR

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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