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Class 2 Device Recall Piccolo Composite Tibia and Femoral Nailing Systems Ball Tip Guide Wire |
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Date Initiated by Firm |
May 10, 2016 |
Date Posted |
June 14, 2016 |
Recall Status1 |
Terminated 3 on January 27, 2017 |
Recall Number |
Z-1991-2016 |
Recall Event ID |
74229 |
510(K)Number |
K102369 K111056 K151010 K153536
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Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
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Product |
Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. |
Code Information |
Catalog Number PFT912250 - Lot Number QTN90712, QTN02700, QTN61401, QTN02785A, QTN61402, QTN83201B, QTN61402A, QTN43801, QTN43801A, QTN43801B, QTN83201C, QTN04161A |
Recalling Firm/ Manufacturer |
CarboFix Orthopedics, Ltd. 11 Ha, Hoslim St. Herzliya Israel
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For Additional Information Contact |
910-208-9406
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Manufacturer Reason for Recall |
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.
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FDA Determined Cause 2 |
Other |
Action |
On May 10, 2016, an advisory notice was issued to all distributors that currently may possess (or supplied to hospital) the product. The notice was sent to a representative of the distributor companies via an e-mail (using confirm receipts for delivery and notification when the email is read), together with a letter to hospital(s) for the representative to use in case the distributor supplied the product to the hospital. The letter requested that the product be returned and also requested a sub-recall. |
Quantity in Commerce |
638 |
Distribution |
AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA |
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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510(K) Database |
510(K)s with Product Code = HSB and Original Applicant = CARBOFIX ORTHOPEDICS LTD. 510(K)s with Product Code = HSB and Original Applicant = CARBOFIX ORTHOPEDICS, LTD. 510(K)s with Product Code = HSB and Original Applicant = N.M.B. MEDICAL APPLICATIONS, LTD.
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