Model 208-70-110, Long Thread Tiger Large Cannulated… recallZ-0609-2017 · Trilliant Surgical Ltd. · initiated Sep 2, 2016
Class II Terminated All recalls posted in November 2016
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
Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The firm sent out written notifcation of the recall on 9/2/16; the letter instructed the consignees to discontinue use of the affected lot, quarantine, and return product of the affected lot in accordance with an included acknowledgement sheet.
Recall details
- Recall number
- Z-0609-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 2, 2016
- Posted by the FDA
- Nov 17, 2016
- Recalling firm
- Trilliant Surgical Ltd.
- Quantity
- 11
- Product code
- HWC
- FDA submissions
- K112737
- Distribution
- CA, AZ, WI, FL, NJ, OH
Product description
Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
Code information (models, lots, serial numbers)
Lot TSL003721
Other devices under the same FDA submission
3 devices cleared under 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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