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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71262

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

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Event summary

Timeline bucket
May 11, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Orthofix, Inc

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

ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.

Z-1819-2015
Recall number
Z-1819-2015
Initiated
May 11, 2015
Classification
Class II
Status
Terminated
Recalling firm
Orthofix, Inc
Quantity
36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.

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

There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.

Code information

All lot codes

Distribution pattern

Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.