Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S
Summary
The FDA issued a Class II for Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Ico by Riverpoint Medical, LLC. 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, .
Details
Source
Device Recall
External ID
Z-0518-2024
Action Date
2023-12-20
Status
Ongoing
Category
device
Product 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.
Lot/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
Quantity Affected: 999 devices
Reason for Recall
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.
Distribution
U.S. Nationwide distribution in the state of CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-25
Company
Portland, OR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Riverpoint Medical, LLC has 10 FDA actions in our database, including 1 recall and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Riverpoint Medical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Riverpoint Medical, LLC have FDA actions?
Riverpoint Medical, LLC has 10 FDA actions in our database, including 1 recall and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0518-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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