Device product

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

Z-2100-2021

May 18, 2021

Class II

Product summary

Firm: Stryker Spine
Event: Event 88217
Status: Terminated
Classification: Class II
Quantity: 559 total
Official record key: device-enforcement:Z-2100-2021

Official wording

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

Code information: lot A1908003

Distribution pattern: US Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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