Recall Z-2452-2015— Trilliant Surgical Ltd.
Class II · Terminated
Class II FDA medical device recall by Trilliant Surgical Ltd., initiated 2015-07-20, terminated 2017-01-26. It names one FDA 510(k) clearance: K081510. Product: 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.. Reason: The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through..
- Recalling firm
- Trilliant Surgical Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-20
- Terminated
- 2017-01-26
- Firm location
- Houston, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
Reason for recall
The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
Data sourced from openFDA. This site is unofficial and independent of the FDA.