CLASS II Device recall · Reported 22 Jan 2020 · FDA Enforcement Report
Gridlock Ankle Screw Driver Bit recalled by Trilliant Surgical
Trilliant Surgical is recalling Gridlock Ankle Screw Driver Bit, distributed nationwide in the US. The recall was initiated on 14 Mar 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-0799-2020
- FDA event ID
- 84350
- Recalling firm
- Trilliant Surgical, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Mar 2019
- FDA classified
- 10 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 14 Mar 2019 | Recall initiated by company | |
| 10 Jan 2020 | Classified by FDA | +302 days |
| 22 Jan 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Where it was distributed
US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
Questions about this recall
Is Gridlock Ankle Screw Driver Bit recalled?
Yes. Trilliant Surgical recalled Gridlock Ankle Screw Driver Bit on 14 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-0799-2020.
Why was it recalled?
A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended.
Which lots are affected?
Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617
Where was it sold?
US Nationwide distribution in the states of CO, CT, IA, TX and WI. 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
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|---|---|---|---|---|---|
| Device | CLASS II | Aresenal Screw Drill Bit recalled by Trilliant Surgical | Trilliant Surgical | Labeling Errors | Nationwide |
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| Device | CLASS II | Instructions for Use and Surgical Cleaning recalled | Trilliant Surgical | Sterility | 29 states |
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| Device | CLASS II | Instructions for Use and Surgical Cleaning recalled | Trilliant Surgical | Sterility | 29 states |
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