FDA recall Z-1914-2025

Stryker GmbH · Class II · device

Product

Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

Reason for recall

Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.

Distribution

Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.

Key facts

Status
Ongoing
Initiation date
2025-05-28
Report date
2025-06-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Selzach, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1914-2025