Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within t...

FDA Device Recall #Z-1776-2022 — Class II — July 13, 2022

Recall Summary

Recall Number Z-1776-2022
Classification Class II — Moderate risk
Date Initiated July 13, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Paragon 28, Inc.
Location Englewood, CO
Product Type Devices
Quantity 145

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

Reason for Recall

Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

Distribution Pattern

US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.

Lot / Code Information

UDI-DI: 00889795114228, Lot: 5007499

Other Recalls from Paragon 28, Inc.

Recall # Classification Product Date
Z-0871-2026 Class II Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, ... Oct 13, 2025
Z-1256-2024 Class II Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT... Dec 21, 2023
Z-1255-2024 Class II Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT... Dec 21, 2023
Z-1254-2024 Class II Phantom TTC Nail, 10.0 X 200mm, Right Dec 21, 2023
Z-1468-2022 Class II HammerTube Implant, 2.75mm, 10¿ Cannulated (Ste... May 26, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.