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
Product summary
- 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
package, and thus compromised the product sterility