FDA Enforcement
Class II
Ongoing
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Recall: Z-1620-2025
·
Reported April 23, 2025
Enforcement
- Recall Number
- Z-1620-2025
- Event ID
- 96555
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 23, 2025
- Initiation Date
- March 28, 2025
- Classification Date
- April 17, 2025
- Address
- Bohnackerweg 1, Selzach, N/A, Switzerland
Description
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Reason
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.
Code Info
Catalog number/REF: 2351-3080S; UDI-DI: 07613327361797; Lot #: KU155697, KU155698, KU155699, KU155700, KU155701, KU155702, KU155703, KU155704, KU155705, KU155706, KU155707, KU155708, KU155709, KU155710, KU155711, KU155712.
Distribution
US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.
Quantity
1588 units