Reported Jun 22, 2016 · Terminated

Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and…

CarboFix Orthopedics, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CarboFix Orthopedics, Ltd. · 11 Ha, Hoslim St. · Herzliya · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • Catalog Number PFT912250 - Lot Number QTN90712, QTN02700, QTN61401, QTN02785A, QTN61402, QTN83201B, QTN61402A, QTN43801, QTN43801A, QTN43801B, QTN83201C, QTN04161A
Amount recalled
638

Where it was sold

Why it was recalled

Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 27, 2017 · Data as of Sep 19, 5:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.