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Class 2 Device Recall Pan Medical US/Zavation ZVplasty |
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Date Initiated by Firm |
March 25, 2021 |
Create Date |
June 01, 2021 |
Recall Status1 |
Terminated 3 on March 20, 2023 |
Recall Number |
Z-1759-2021 |
Recall Event ID |
87661 |
Product Classification |
Cement, bone, vertebroplasty - Product Code NDN
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Product |
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
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Code Information |
Lot Numbers: 13378ZV, 11141ZV, 10815ZV, 13971ZV, 13921ZV, 13577ZV, 13133ZV, 13033ZV, 11793ZV, 11695ZV, 12132ZV, 14105ZV, 12280ZV, 14389ZV, 13884ZV, 11956ZV, 11470ZV, 11342ZV, 10902ZV, 10516ZV, 14358ZV, 12266ZV, 10866ZV, 10651ZV, 14207ZV, 14021ZV, 11231ZV, 11465ZV, 12025ZV, 11537ZV, 11415ZV, 10998ZV, 11072ZV, 13883ZV |
Recalling Firm/ Manufacturer |
Zavation 220 Lakeland Pkwy Flowood MS 39232-9552
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For Additional Information Contact |
Quality Department 601-919-1119
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Manufacturer Reason for Recall |
Products distributed as sterile may not have been adequately sterilized
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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 |
516 units |
Distribution |
US nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
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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.
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