Z-1991-2016 Class II Terminated
FDA device recall Z-1991-2016 was initiated by CarboFix Orthopedics, Ltd. on May 10, 2016 and is designated Class II. Reason for recall: Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility. The recall status is terminated (terminated January 27, 2017). Affected quantity: 638.
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2016
- Initiation Date
- May 10, 2016
- Termination Date
- January 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 638
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.
Reason for Recall
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.
Distribution Pattern
AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA
Code Information
Catalog Number PFT912250 - Lot Number QTN90712, QTN02700, QTN61401, QTN02785A, QTN61402, QTN83201B, QTN61402A, QTN43801, QTN43801A, QTN43801B, QTN83201C, QTN04161A