Recall Z-1991-2016— CarboFix Orthopedics, Ltd.
Class II · Terminated
Class II FDA medical device recall by CarboFix Orthopedics, Ltd., initiated 2016-05-10, terminated 2017-01-27. It names 4 FDA 510(k) clearances: K153536, K151010, K111056 and 1 more. 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.. Reason: Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility..
- Recalling firm
- CarboFix Orthopedics, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-10
- Terminated
- 2017-01-27
- Firm location
- Herzliya, Israel
510(k) clearances named in this recall
4 on FDA's record- K153536 — Piccolo Composite® Nailing System
- K151010 — Piccolo Composite Nailing System
- K111056 — PICCOLO COMPOSITE NAILING SYSTEM
- K102369 — PICCOLO COMPOSITE NAILING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.