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U.S. Department of Health and Human Services

Class 2 Device Recall Inconix Knotless Anchor

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  Class 2 Device Recall Inconix Knotless Anchor see related information
Date Initiated by Firm October 25, 2023
Date Posted December 08, 2023
Recall Status1 Open3, Classified
Recall Number Z-0518-2024
Recall Event ID 93390
510(K)Number K231278  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
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.
Code Information 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
Recalling Firm/
Manufacturer		 Riverpoint Medical, LLC
825 NE 25th Ave
Portland OR 97232-2304
For Additional Information Contact Doug King
503-517-8001
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 999 devices
Distribution U.S. Nationwide distribution in the state of CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = Riverpoint Medical, LLC
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