Riverpoint Medical, LLC Recall 93390
Description: 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.
Riverpoint Medical, LLC Recall 93390 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0518-2024 |
| Event ID | 93390 |
| Event Description | 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 Type | Devices |
| Distribution | U.S. Nationwide distribution in the state of CA. |
| Quantity | 999 devices |
| Recall 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. |
| Device Classification | 20231220 |
| Device Code Info | 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 |
| Center Classification Date | 20231208 |
| Recall Initiation Date | 20231025 |
| Recalling Firm | Riverpoint Medical, LLC |
| Initial Notification | Letter |
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