Stryker Spine Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

Urgent Medical Device Recall notification letters dated 5/14/21 were sent to customers. Actions needed NOTE: due to the potential hazards/risks associated with use of product associated with these shipments, please urgently quarantine the in-scope product. 1. Immediately review the Product Recall Notification. Please forward this information to all appropriate personnel within your organization. Maintain awareness of this communication internally until all required actions have been completed within your facility. 2. Immediately check your internal inventory to locate the affected products. Quarantine and discontinue use of any affected Cortoss Bone Augmentation Material. Your local Stryker Representative is available to assist with removal of this product. 3. Complete the enclosed business reply form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please return the BRF, even if you dont have any affected product on hand, via email to Instruments.Recalls@stryker.com. 4. Upon receipt of the completed BRF, replacement(s) will be shipped to your facility. 5. If you have further distributed this product to other organizations, please provide contact details on the BRF so that Stryker can inform the recipients appropriately. If you have any questions or concerns, please contact Regulatory Compliance at 201-749-8090.