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.
Recall
- Recall Number
- Z-1991-2016
- Event Number
- 74229
- Firm
- CarboFix Orthopedics, Ltd. 11 Ha, Hoslim St. Herzliya Israel
- FEI Number
- 3008820440
- Product Code
- HSB
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 10, 2016
- Posted
- June 14, 2016
- Terminated
- January 27, 2017
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.
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.
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.
AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA
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