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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76158

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

Open FDA event record

Event summary

Timeline bucket
December 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mako Surgical 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

MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

Z-1411-2017
Recall number
Z-1411-2017
Initiated
December 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Mako Surgical Corporation
Quantity
777

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

Code information

Part Item #: 204863 - THA 1.0 Application User Guide Part Item #: 207116 - THA 2.0 Application User Guide Part Item #: 208692 - THA 2.1 Application User Guide Part Item #: 209711 - MAKOplasty THA Application User Guide Part Item #: 210555 - MAKIplast THA 3.1 Application User Guide Part Item#: 212026 - THA Application User Guide 2.1-2.1.1 THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1 Part Item # 204863 THA 1.0 Application User Guide Part Item # 207116 THA 2.0 Application User Guide Part Item # 208692 THA 2.1 Application User Guide Part Item # 209711 MAKOplasty THA Application User Guide Part Item # 210555 MAKIplast THA 3.1 Application User Guide Part Item # 212026 THA Application User Guide

Distribution pattern

US nationwide distribution.