Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84350

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 14, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Trilliant Surgical, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.

Z-0799-2020
Recall number
Z-0799-2020
Initiated
March 14, 2019
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical, LLC
Quantity
20 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617

Distribution pattern

US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None