Iconix Knotless 1.4mm Anchor recalled due to inserter failure risk
Riverpoint Medical is recalling Iconix Knotless 1.4mm surgical anchors because the inserter can fail or bend when used in hard bone, potentially damaging sutures during insertion or use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with documented mechanical failure mode (inserter failure in hard bone) leading to suture damage risk. No injuries or hospitalizations reported in the source. Scores as High per rubric criterion for risk-of-harm products without reported illness.
Plain-English summary
Riverpoint Medical, LLC is recalling Iconix Knotless 1.4mm Anchor with XBraid S surgical anchors (REF 3911-714-520 in Blue/Black and REF 3911-714-521 in Black/White). Approximately 999 devices were affected, with lot numbers 23080433 and 23081617, distributed nationwide in the United States.
These anchors are medical devices used for soft-tissue to bone fixation in multiple joints including the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder. The recall was initiated because use of a 1.4mm drill in hard bone conditions can cause increased insertion forces that lead to the inserter tool bending or failing.
When the inserter bends, it may move away from the intended drill hole location, causing damage to the suture construct during the insertion procedure. This suture damage may result in sutures breaking during surgical use, potentially compromising the soft-tissue fixation.
Patients and healthcare providers should contact Riverpoint Medical for guidance regarding implants in use or in inventory.
The recalled product
- 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, wri
- Manufacturer
- Riverpoint Medical, LLC
- Category
- Medical Device — Surgical Anchor
- Hazard
- inserter-failure
- suture-damage
- surgical-complication
Distribution
Distributed nationwide across the United States.
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