CarboFix Orthopedics, Ltd.: Medical Device Recall in 2016 - (Recall #: Z-1991-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 10, 2016

Date Posted: June 22, 2016

Recall Number: Z-1991-2016

Event ID: 74229

Reason for Recall:

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

Status: Terminated

Product Quantity: 638

Code Information:

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

Distribution Pattern:

AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA

Voluntary or Mandated:

Voluntary: Firm initiated