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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76508

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

Open FDA event record

Event summary

Timeline bucket
February 20, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Orthosoft, Inc. dba Zimmer CAS

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

SmartTools Knee System Orthopedic Stereotaxic Instrument

Z-1868-2017
Recall number
Z-1868-2017
Initiated
February 20, 2017
Classification
Class II
Status
Terminated
Quantity
84

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P

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

There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P

Code information

Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711

Distribution pattern

Nationwide Distribution