Riverpoint Medical, LLC 2023-12-20 Health serious FDA
Health · FDA · Recall #FDA-Z-0518-2024
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix… Recall
Issued December 20, 2023 · Riverpoint Medical, LLC
In December 2023, Riverpoint Medical, LLC recalled the Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Riverpoint Medical, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Riverpoint Medical, LLC
- Category
- Health
- Recall date
- December 20, 2023
- Units affected
- Not reported
- Sold at
- U.S. Nationwide distribution in the state of CA.
- Recall number
- FDA-Z-0518-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Riverpoint Medical, LLC has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.