Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glauc...

FDA Device Recall #Z-1111-2019 — Class II — March 12, 2019

Recall Summary

Recall Number Z-1111-2019
Classification Class II — Moderate risk
Date Initiated March 12, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Beaver Visitec
Location Waltham, MA
Product Type Devices
Quantity 196 boxes (10units/box)

Product Description

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

Reason for Recall

Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device

Distribution Pattern

Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS

Lot / Code Information

Lot Number: 6008554

Other Recalls from Beaver Visitec

Recall # Classification Product Date
Z-1088-2019 Class III Micro Knife 5.0mm 30¿, Part Number 0001522 ... Feb 19, 2019
Z-1066-2019 Class II BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm ... Nov 30, 2018
Z-3045-2018 Class II Beaver Accu-Temp High Temperature Cautery, 2 in... Jul 19, 2018
Z-2740-2018 Class II Slit Knife 2.6mm 45degree Bevel Up, Model Numbe... Jun 18, 2018
Z-2342-2018 Class II Safety Sideport Knife 1.0mm 45¿, REF 378210 ... May 14, 2018

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.