Class 2 Device Recall Cortoss

• Date Initiated by Firm: April 01, 2020
• Create Date: May 05, 2020
• Recall Status: Terminated on August 27, 2020
• Recall Number: Z-1900-2020
• Recall Event ID: 85400
• 510(K)Number: K080108
• Product Classification: Cement, bone, vertebroplasty - Product Code NDN
• Product: Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
• Code Information: Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 2 Pearl Ct; Allendale NJ 07401-1611
• For Additional Information Contact: Regulatory Compliance; 201-749-8090
• Manufacturer 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.
• FDA Determined Cause: Storage
• Action: On April 1, 2020, the firm distributed Urgent Medical Device Recall letters to all affected customers. Customers were informed that the product had been transported outside of the required refrigerated temperature conditions, which protect the active material components from degradation, and help maintain optimal product set time as well as optimal mechanical properties. Customers were instructed to do the following: NOTE: due to the potential hazards/risks associated with future 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. 2. Immediately check your internal inventory to locate the product listed on the attached business reply form and list the quantity of units on the form. Each form is hospital specific and will include shipment(s) details, including customer P.O. and delivery date. 3. Use the Business Reply Form to reconcile any affected product. Complete the Business Reply Form even if there is no affected product identified. 4. Return the enclosed business reply form by email to Spine-RegulatoryActions@Stryker.com or fax to 201.575.4675 to confirm receipt of this notification. 5. Upon receipt of the completed Business Reply Form, Stryker will contact you to arrange for the return and replacement of your product(s). 6. After completion of the actions as described above, there are no additional actions that users can and should take to ensure that the product operates safely. - If you desire additional training associated with these instructions, please contact our Regulatory Compliance team at 201.749.8090 or by email at Spine-RegulatoryActions@Stryker.com. 7. Maintain awareness of this communication internally until all required actions have been completed within your facility. 8. Inform Stryker if any of the subject devices have been distributed to othe
• Quantity in Commerce: 115
• Distribution: US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NDN