FDAClass IIMay 13, 2020

Cortoss Bone Augmentation Material recall

Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010

Why was Cortoss Bone Augmentation Material recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979

Product
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Recalling firm
Howmedica Osteonics Corp.
Quantity
115
Distribution
US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin
Recall date
May 13, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls