FDA recall Z-2170-2021

Product

Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S

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-2170-2021