FDA recall Z-2171-2021

Stryker GmbH · Class II · device

Product

Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S

Reason for recall

The devices have a different inner diameter than the diameter specified on the outer box label.

Distribution

US Nationwide Distribution

Key facts

Status
Ongoing
Initiation date
2021-05-27
Report date
2021-08-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Selzach, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2171-2021