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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82738

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 25, 2019
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

2 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 2

2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)

Z-1823-2019
Recall number
Z-1823-2019
Initiated
April 25, 2019
Classification
Class II
Status
Terminated
Recalling firm
Mako Surgical Corporation
Quantity
39

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The bearings of the saw attachments were ungreased.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The bearings of the saw attachments were ungreased.

Code information

Catalog Number: 212480 Lot Number: 35040918 UDI: (01)00848486032128(10)35040918

Distribution pattern

AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands

device · product 2 of 2

2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)

Z-1824-2019
Recall number
Z-1824-2019
Initiated
April 25, 2019
Classification
Class II
Status
Terminated
Recalling firm
Mako Surgical Corporation
Quantity
7

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The bearings of the saw attachments were ungreased.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The bearings of the saw attachments were ungreased.

Code information

Catalog Number: 212186 Lot Number: 35051018 and 35050918 UDI: (01)00848486032111(10)35051018 and (01)00848486032111(10)35050918

Distribution pattern

AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands