Reported Dec 20, 2023 · Ongoing
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S…
Riverpoint Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Riverpoint Medical, LLC · 825 NE 25th Ave · Portland, OR · 97232-2304
Is this the product you have?
- 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.
- Lot codes and dates
- Product Code3911-7 14-520
- UDI-DI Code00840277402172
- Lot Number23080433
- Product Code3911-7 14-521
- UDI-DI Code00840277402189
- Lot Number23081617
- Amount recalled
- 999 devices
Where it was sold
- Nationwide
- CA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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