Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anch
Summary
The FDA issued a Class II for Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, by Paragon 28, Inc.. Reason: Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery..
Details
Source
Device Recall
External ID
Z-1776-2022
Action Date
2022-09-28
Status
Ongoing
Category
device
Product Description
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Lot/Code Info: UDI-DI: 00889795114228, Lot: 5007499
Quantity Affected: 145
Reason for Recall
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Distribution
US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-13
Company
Englewood, CO
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 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Paragon 28, Inc. has 38 FDA actions in our database, including 8 recalls and 30 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 (Paragon 28, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Paragon 28, Inc. have FDA actions?
Paragon 28, Inc. has 38 FDA actions in our database, including 8 recalls and 30 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1776-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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