RecallRadar

FDA Device recall Z-2101-2021

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

On 2021-07-28 the FDA classified a Class II recall of Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979 by Stryker Spine, citing the products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2101-2021
ClassificationClass II
Statusterminated
Initiated2021-05-18
Published2021-07-28
Last updated2026-09-13 11:56 UTC
CompanyStryker Spine
DistributionUS

Product

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

Reason

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

Identifiers

code_infolots A1903054, A1906006

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2101-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.