FDA-Device2021-07-28Class II

Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979

Stryker Spine
Hazard

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

Sold states
US Nationwide Distribution
Affected count
559 total
Manufactured in
2 Pearl Ct, N/A, Allendale, NJ, United States
Products
Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2101-2021

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