Class 2 Device Recall Pan Medical US/Zavation

• Date Initiated by Firm: March 25, 2021
• Create Date: June 01, 2021
• Recall Status: Terminated on March 20, 2023
• Recall Number: Z-1700-2021
• Recall Event ID: 87661
• 510(K)Number: K130616 K141419
• Product Classification: Cement, bone, vertebroplasty - Product Code NDN
• Product: 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
• Code Information: Product Batch: 19102741, 200127, 2001246
• 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: 56 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.

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