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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Riverpoint Medical, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Riverpoint Medical, LLC is recalling Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anc due to 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, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by 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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026