Recall Z-2101-2021— Stryker Spine

Name: FDA recall Z-2101-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-18

Class II · Terminated

Class II FDA medical device recall by Stryker Spine, initiated 2021-05-18, terminated 2022-04-15. It names one FDA 510(k) clearance: K080108. 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..

Recalling firm: Stryker Spine
Classification: Class II
Status: Terminated
Initiated: 2021-05-18
Terminated: 2022-04-15
Firm location: Allendale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K080108 — CORTOSS BONE AUGMENTATION MATERIALOrthovita, Inc.·cleared 2009-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.