Tiger Screw Sterilization Tray Base Assembly Model… recallZ-0960-2017 · Trilliant Surgical Ltd. · initiated Dec 8, 2016
Class II Terminated All recalls posted in January 2017
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
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Trilliant Surgical Ltd. sent an Urgent Medical Device Recall letter dated December 8, 2016, to all affected consignees. The letter instructed the consignees to 1) identify any/all affected product; 2) document any/all identified product via a provided response form and return to Trilliant Surgical; 3) exchange product upon receipt of replacements; and 4) return any/all affected product as originally identified and reported on the return response form. Customers with questions were instructed to call 800-495-2919.
Recall details
- Recall number
- Z-0960-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 8, 2016
- Posted by the FDA
- Jan 6, 2017
- Recalling firm
- Trilliant Surgical Ltd.
- Quantity
- 50 units
- Product code
- HWC
- FDA submissions
- K153338
- Distribution
- Nationwide Distribution
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.
Code information (models, lots, serial numbers)
Lot: TSL003191, TSL003637, TSL004101, TSL004395
Other devices under the same FDA submission
1 device cleared under K153338 — 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 205-55-040Trilliant 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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