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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70374

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

Open FDA event record

Event summary

Timeline bucket
January 22, 2015
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

Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.

Z-1128-2015
Recall number
Z-1128-2015
Initiated
January 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Mako Surgical Corporation
Quantity
228 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated

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

When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated

Code information

All lots, Part Numbers: 201000, 203999, 207300, and 209930.

Distribution pattern

Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.

Field note

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