FDAClass IIJuly 28, 2021

Cortoss Bone Augmentation Material 10cc Cartridge recall

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

Why was Cortoss Bone Augmentation Material 10cc Cartridge recalled?

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

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?

lots A1903054, A1906006

Product
Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
Recalling firm
Stryker Spine
Quantity
559 total
Distribution
US Nationwide Distribution
Recall date
July 28, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls