FDA recall Z-1621-2025

Stryker GmbH · Class II · device

Product

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

US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.

Key facts

Status
Ongoing
Initiation date
2025-03-28
Report date
2025-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Selzach, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1621-2025