FDA recall Z-2100-2021

Stryker Spine · Class II · device

Product

Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962

Reason for recall

The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2021-05-18
Report date
2021-07-28
Termination date
2022-04-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allendale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2100-2021