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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 Wiresee related information
Date Initiated by FirmMay 10, 2016
Date PostedJune 14, 2016
Recall Status1 Terminated 3 on January 27, 2017
Recall NumberZ-1991-2016
Recall Event ID 74229
510(K)NumberK102369 K111056 K151010 K153536 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductPiccolo 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
FEI Number 3008820440
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
ActionOn 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 Commerce638
DistributionAL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HSB
510(K)s with Product Code = HSB
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