Z-0660-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2024
- Initiation Date
- November 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,999 units
Product Description
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
Reason for Recall
Potential for the outer stainless-steel tube to break or detach.
Distribution Pattern
Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.
Code Information
Model/Catalog Number: OPT14-5011. Lot Code: J20499-01, J21637-01, J21999-01, J21995-01, J22003-01, J23738-01, J23739-01, J23740-01, J23743-01, J24697-01, J24710-01, J24711-01, J26812-01, J30100-01. Component, no UDI held by Kirwan Surgical Products.