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U.S. Department of Health and Human Services

Class 2 Device Recall Cortoss Bone Augmentation Material

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  Class 2 Device Recall Cortoss Bone Augmentation Material see related information
Date Initiated by Firm May 18, 2021
Create Date July 20, 2021
Recall Status1 Terminated 3 on April 15, 2022
Recall Number Z-2100-2021
Recall Event ID 88217
510(K)Number K080108  
Product Classification Cement, bone, vertebroplasty - Product Code NDN
Product Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
Code Information lot A1908003
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact
201-749-8090
Manufacturer Reason
for Recall		 The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
FDA Determined
Cause 2		 Storage
Action 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.
Quantity in Commerce 559 total
Distribution US Nationwide Distribution
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 and Original Applicant = ORTHOVITA, INC.
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