Device product
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Z-1620-2025
Product summary
- Firm
- Stryker GmbH
- Event
- Event 96555
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1588 units
- Official record key
device-enforcement:Z-1620-2025
Official wording
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 information: 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 pattern: US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.
Derived failure modes
-
Unknown
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.