Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE recallZ-2464-2015 · Trilliant Surgical Ltd. · initiated Jul 20, 2015
Class II Terminated All recalls posted in August 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Trilliant Surgical Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Component design/selection
What the company is doing
Trilliant sent an Important Medical Device Adivsory Notice dated November 6, 2013, to all affected customers. The letter instructed customers that they have the option of exchanging affected instruments for trays that meet specification at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical sales representative or the Customer Service Department directly at 1-800-495-2919, or via email at [email protected].
Recall details
- Recall number
- Z-2464-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 20, 2015
- Posted by the FDA
- Aug 26, 2015
- Recalling firm
- Trilliant Surgical Ltd.
- Quantity
- 71 units
- Product code
- HWC
- FDA submissions
- K081510, K112737
- Distribution
- Nationwide Distribution
Product description
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.
Code information (models, lots, serial numbers)
Lot Numbers ALU120514552473 and 45479
Other devices under the same FDA submission
3 devices cleared under K081510, K112737 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Tiger 202-20-018Trilliant Surgical, LLC · Screw, Fixation, Bone1 report
- Tiger 202-30-026Trilliant Surgical, LLC · Screw, Fixation, Bone1 report
- Tiger 202-30-028Trilliant Surgical, LLC · Screw, Fixation, Bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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