CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report
Aresenal Screw Drill Bit recalled by Trilliant Surgical
Trilliant Surgical is recalling Aresenal Screw Drill Bit, distributed nationwide in the US. The recall was initiated on 10 Oct 2019 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-1892-2020
- FDA event ID
- 85374
- Recalling firm
- Trilliant Surgical, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2019
- FDA classified
- 5 May 2020
- Reported
- 13 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 10 Oct 2019 | Recall initiated by company | |
| 5 May 2020 | Classified by FDA | +208 days |
| 13 May 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability.
Product as listed by the FDA
3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion
Where it was distributed
US Nationwide distribution in the state of CA. OUS: None
Questions about this recall
Is Aresenal Screw Drill Bit recalled?
Yes. Trilliant Surgical recalled Aresenal Screw Drill Bit on 10 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-1892-2020.
Why was it recalled?
Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability.
Which lots are affected?
Lot # TSL008495A
Where was it sold?
US Nationwide distribution in the state of CA. OUS: None
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.
More recalls from Trilliant Surgical
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | Instructions for Use and Surgical Cleaning recalled | Trilliant Surgical | Sterility | 29 states |
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