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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76540

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

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Event summary

Timeline bucket
February 10, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
United Orthopedic Corporation

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

UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.

Z-1692-2017
Recall number
Z-1692-2017
Initiated
February 10, 2017
Classification
Class II
Status
Terminated
Quantity
33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.

Code information

Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)

Distribution pattern

Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.