Recall Z-2421-2015— 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: 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: 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 cutting efficiency of the Countersinks was out of specification..
- 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
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: 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 cutting efficiency of the Countersinks was out of specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.