Recall Z-1900-2020— Howmedica Osteonics Corp.

Name: FDA recall Z-1900-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-01

Class II · Terminated

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2020-04-01, terminated 2020-08-27. It names one FDA 510(k) clearance: K080108. Product: Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010. Reason: Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2020-04-01
Terminated: 2020-08-27
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, Catalog Nos. 2101-0005 and 2101-0010

Reason for recall

Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.

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