PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 28, 2021 Initiated: May 18, 2021 #Z-2100-2021

Product Description

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.

Details

Recalling Firm
Stryker Spine
Units Affected
559 total
Distribution
US Nationwide Distribution
Location
Allendale, NJ

Frequently Asked Questions

What product was recalled?
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962. Recalled by Stryker Spine. Units affected: 559 total.
Why was this product recalled?
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2100-2021.