CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report
Tiger Cannulated Tray Lid Part # 210-00-001-1 Non-sterile recalled
Trilliant Surgical is recalling Tiger Cannulated Tray Lid Part # 210-00-001-1 Non-sterile, distributed nationwide in the US. The recall was initiated on 20 Jul 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2464-2015
- FDA event ID
- 71813
- Recalling firm
- Trilliant Surgical, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2015
- FDA classified
- 26 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 20 Jul 2015 | Recall initiated by company | |
| 26 Aug 2015 | Classified by FDA | +37 days |
| 2 Sep 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless 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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.
Which lots are affected?
Lot Numbers ALU120514552473 and 45479
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Trilliant Surgical
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Aresenal Screw Drill Bit recalled by Trilliant Surgical | Trilliant Surgical | Labeling Errors | Nationwide |
| Device | CLASS II | Instructions for Use and Surgical Cleaning recalled | Trilliant Surgical | Sterility | 29 states |
| Device | CLASS II | Instructions for Use and Surgical Cleaning recalled | Trilliant Surgical | Sterility | 29 states |
| Device | CLASS II | Instructions for Use and Surgical Cleaning recalled | Trilliant Surgical | Sterility | 29 states |
| Device | CLASS II | Instructions for Use and Surgical Cleaning recalled | Trilliant Surgical | Sterility | 29 states |
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