Recall Z-0518-2024 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
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.
| Date | Dec 8, 2023 (initiated Oct 25, 2023) |
| Status | Open, Classified |
| 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. Ma |
| Quantity | 999 devices |
| Distribution | U.S. Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231278 | Knotless Suture Anchor Riverpoint Medical, LLC, Aug 1, 2023 |