Z-0663-2025 Class II Ongoing
FDA device recall Z-0663-2025 was initiated by Microline Surgical, Inc. on November 5, 2024 and is designated Class II. Reason for recall: A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off. The recall status is ongoing. Affected quantity: 200 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2024
- Initiation Date
- November 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 units
Product Description
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Reason for Recall
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
Distribution Pattern
Worldwide - US Nationwide in the state of OK and the country of Japan.
Code Information
Microline Catalog #: 3122; UDI/DI: 811099010036; Lot Number: 00172110.