Recall Z-1991-2016 · HSB Rod, Fixation, Intramedullary And Accessories
CarboFix Orthopedics, Ltd.
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.
| Date | Jun 14, 2016 (initiated May 10, 2016) |
| Status | Terminated |
| Reason | Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility. |
| Root cause | Other |
| Action | 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. |
| Quantity | 638 |
| Distribution | AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102369 | PICCOLO COMPOSITE NAILING SYSTEM N.M.B. Medical Applications, Ltd., Jan 31, 2011 |
| K111056 | PICCOLO COMPOSITE NAILING SYSTEM CarboFix Orthopedics , Ltd., May 3, 2011 |
| K151010 | Piccolo Composite Nailing System CarboFix Orthopedics , Ltd., Jul 28, 2015 |
| K153536 | Piccolo Composite® Nailing System CarboFix Orthopedics , Ltd., Jan 6, 2016 |