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/ 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 |
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
|