Grappler™ Suture Anchor System P44-110-3010-SKRecalls & reported problems

Paragon 28, Inc. · Grappler Suture Anchor, Titanium, ø3.0 x 10mm, Sterile Kit · Class 2

All models of Grappler Suture Anchor System (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Jul 13, 2022Class IIOpen, Classified
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Z-1776-2022 · Root cause: Device Design · Recall details · FDA record ↗

Device details

UDI-DI	`00889795114228`
Brand	Grappler™ Suture Anchor System
Model	P44-110-3010-SK
Company	Paragon 28, Inc.
Product code	MBI · Fastener, fixation, nondegradable, soft tissue
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Apr 22, 2025

Device type (GMDN): General internal orthopaedic fixation system implantation kit

A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

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All Fastener, fixation, nondegradable, soft tissue devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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