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U.S. Department of Health and Human Services

Class 2 Device Recall Piccolo Composite Tibia and Femoral Nailing Systems Ball Tip Guide Wire

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  Class 2 Device Recall Piccolo Composite Tibia and Femoral Nailing Systems Ball Tip Guide Wire see related information
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  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
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
For Additional Information Contact
910-208-9406
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.
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
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 = 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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