Class 2 Device Recall Pan Medical US/Zavation OsteoFlex

• Date Initiated by Firm: March 25, 2021
• Create Date: June 01, 2021
• Recall Status: Terminated on March 20, 2023
• Recall Number: Z-1768-2021
• Recall Event ID: 87661
• Product Classification: Cement, bone, vertebroplasty - Product Code NDN
• Product: OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
• Code Information: Lot Numbers: 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, 13876ZV
• Recalling Firm/ Manufacturer: Zavation; 220 Lakeland Pkwy; Flowood MS 39232-9552
• For Additional Information Contact: Quality Department; 601-919-1119
• Manufacturer Reason for Recall: Products distributed as sterile may not have been adequately sterilized
• FDA Determined Cause: Vendor change control
• Action: Zavation initially notified their consignees of the problem by email beginning on 03/24/2021 and requested they quarantine the product. The firm sent a subsequent email beginning on 04/13/2021 requesting the return of the product. The recall is being conducted to the user level.
• Quantity in Commerce: 846 units
• 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.