Recall Z-0960-2017— Trilliant Surgical Ltd.
Class II · Terminated
Class II FDA medical device recall by Trilliant Surgical Ltd., initiated 2016-12-08, terminated 2017-05-17. It names one FDA 510(k) clearance: K153338. Product: Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.. Reason: Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively..
- Recalling firm
- Trilliant Surgical Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-08
- Terminated
- 2017-05-17
- 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
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Reason for recall
Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
Data sourced from openFDA. This site is unofficial and independent of the FDA.