BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair...

FDA Device Recall #Z-2061-2023 — Class II — May 4, 2023

Recall Summary

Recall Number Z-2061-2023
Classification Class II — Moderate risk
Date Initiated May 4, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Location GAATON, N/A
Product Type Devices
Quantity N/A

Product Description

BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045160

Reason for Recall

Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.

Lot / Code Information

UDI-DI: 10818674025772 Lot Numbers: 21E28, 21R15, 21R16, 21R32, 21R35, 22C19, 22E29, 22F10, 22F35, 22J07, 22J08, 22J09, 22J18, 22J19, 22J27, 22J28, 22J33, 22K23, 22K24, 22K32, 22K33, 22K38, 22M03, 22M04, 22M24, 22P03, 22P09, 22P10, 22P11, 22P13, 22P14, 22P16

Other Recalls from T.A.G. MEDICAL PRODUCTS CORPORATION, ...

Recall # Classification Product Date
Z-2065-2023 Class II Betta Link LG Reusable Fishmouth Guide-Intended... May 4, 2023
Z-2062-2023 Class II BETTA LINK SR REUSABLE PRONGED GUIDE- Intended ... May 4, 2023
Z-2064-2023 Class II Betta Link LG Reusable ProngED Guide - Intended... May 4, 2023
Z-2060-2023 Class II BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for... May 4, 2023
Z-2063-2023 Class II BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended... May 4, 2023

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.