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Piccolo Composite Tibia and Femoral Nailing Systems - Ball… recallZ-1991-2016 · CarboFix Orthopedics, Ltd. · initiated May 10, 2016

Class II Terminated All recalls posted in June 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CarboFix Orthopedics, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1991-2016
Recall class
Class II
Status
Terminated
Initiated by the company
May 10, 2016
Posted by the FDA
Jun 14, 2016
Recalling firm
CarboFix Orthopedics, Ltd.
Quantity
638
Product code
HSB
FDA submissions
K102369, K111056, K151010, K153536
Distribution
AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA

Product description

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 (models, lots, serial numbers)

Catalog Number PFT912250 - Lot Number QTN90712, QTN02700, QTN61401, QTN02785A, QTN61402, QTN83201B, QTN61402A, QTN43801, QTN43801A, QTN43801B, QTN83201C, QTN04161A

Other devices under the same FDA submission

12 devices cleared under K102369, K111056, K151010, K153536 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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