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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80195

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 27, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Trilliant Surgical Ltd.

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

2 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 2

Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile

Z-2338-2018
Recall number
Z-2338-2018
Initiated
March 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical Ltd.
Quantity
94

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.

Code information

Lot: 603599

Distribution pattern

U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO

device · product 2 of 2

Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile

Z-2339-2018
Recall number
Z-2339-2018
Initiated
March 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Trilliant Surgical Ltd.
Quantity
90

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.

Code information

Lot: 603600

Distribution pattern

U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO