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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-1707-2021
Recall Event ID 87661
510(K)Number K141419  
Product Classification Cement, bone, vertebroplasty - Product Code NDN
Product ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures.
Code Information Lot: 19113043, 20041107
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 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 2 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
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