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U.S. Department of Health and Human Services

Class 2 Device Recall Pan Medical US/Zavation ZVplasty

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  Class 2 Device Recall Pan Medical US/Zavation ZVplasty see related information
Date Initiated by Firm March 25, 2021
Create Date June 01, 2021
Recall Status1 Terminated 3 on March 20, 2023
Recall Number Z-1708-2021
Recall Event ID 87661
510(K)Number K141419  
Product Classification Cement, bone, vertebroplasty - Product Code NDN
Product ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.
Code Information lot: 19113041, 20071853, 20071714, 2003803
Recalling Firm/
220 Lakeland Pkwy
Flowood MS 39232-9552
For Additional Information Contact Quality Department
Manufacturer Reason
for Recall
Products distributed as sterile may not have been adequately sterilized
FDA Determined
Cause 2
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 11 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 and Original Applicant = ZAVATION LLC