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Recall Observatory FDA recall evidence

Device 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.

Z-1991-2016

May 10, 2016

Class II

Product summary

Firm
CarboFix Orthopedics, Ltd.
Event
Event 74229
Status
Terminated
Classification
Class II
Quantity
638
Official record key
device-enforcement:Z-1991-2016

Official wording

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

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    package, and thus compromised the product sterility