| Class 2 Device Recall Pan Medical US/Zavation ZVplasty | |
Date Initiated by Firm | March 25, 2021 |
Create Date | June 01, 2021 |
Recall Status1 |
Terminated 3 on March 20, 2023 |
Recall Number | Z-1765-2021 |
Recall Event ID |
87661 |
Product Classification |
Cement, bone, vertebroplasty - Product Code NDN
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Product | ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures. |
Code Information |
Lot Numbers: 13978ZV, 13966ZV, 13873ZV, 13643ZV, 13185ZV, 12594ZV, 11766ZV, 11548ZV, 11391ZV, 11139ZV, 10781ZV, 14390ZV, 13976ZV, 13711ZV, 13413ZV, 12930ZV, 12331ZV, 12300ZV, 12199ZV, 14349ZV, 11271ZV, 11847ZV, 11274ZV |
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 | 302 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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