Z-1621-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6407 units
Product Description
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
Reason for Recall
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Distribution Pattern
US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.
Code Information
Catalog number/REF: 2351-3100S; UDI-DI: 07613327361803; Lot #: KU164143, KU164755, KU164756, KU164757, KU164758, KU164759, KU164760, KU164761, KU164762, KU164763, KU164764, KU164765, KU164766, KU164767, KU164768, KU164769, KU164770, KU164771, KU164772, KU164773, KU164774, KU164775, KU164776, KU164777, KU164778, KU164779, KU164780, KU164781, KU164782, KU164783, KU164784, KU165161, KU165162, KU165163, KU165164, KU165165, KU165166, KU165167, KU165168, KU165169, KU165170, KU165171, KU165172, KU165173, KU165174, KU165175, KU184035, KU184036, KU184039, KU184041, KU184042, KU184044, KU184045, KU184046, KU184047, KU184049.