CLASS II Device recall · Reported 23 Nov 2016 · FDA Enforcement Report
Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw recalled
Trilliant Surgical is recalling Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, distributed in Arizona, California, Florida, New Jersey, Ohio, Wisconsin. The recall was initiated on 2 Sep 2016 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-0609-2017
- FDA event ID
- 75187
- Recalling firm
- Trilliant Surgical, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Sep 2016
- FDA classified
- 17 Nov 2016
- Reported
- 23 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 2 Sep 2016 | Recall initiated by company | |
| 17 Nov 2016 | Classified by FDA | +76 days |
| 23 Nov 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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"
Where it was distributed
CA, AZ, WI, FL, NJ, OH
Questions about this recall
Is Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw recalled?
Yes. Trilliant Surgical recalled Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw on 2 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0609-2017.
Why was it 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.
Which lots are affected?
Lot TSL003721
Where was it sold?
CA, AZ, WI, FL, NJ, OH
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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