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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63223

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

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Event summary

Timeline bucket
May 09, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aesculap, 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

Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)

Z-0082-2013
Recall number
Z-0082-2013
Initiated
May 09, 2012
Classification
Class II
Status
Terminated
Recalling firm
Aesculap, Inc.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The manufacturer informed the recalling firm of a potential laser marking error in size identification on two Columbus 4-IN-1 Femoral Cutting Guide Instruments. The guides are correctly dimensioned, but the laser markings have been incorrectly etched.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The manufacturer informed the recalling firm of a potential laser marking error in size identification on two Columbus 4-IN-1 Femoral Cutting Guide Instruments. The guides are correctly dimensioned, but the laser markings have been incorrectly etched.

Code information

NQ083R

Distribution pattern

Within the US, product was distributed to PA and TN.