Exact FDA event identifier

Event 69465

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

Event summary

Timeline bucket: October 07, 2014
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

3 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 3

RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

Z-0828-2015

Recall number: Z-0828-2015
Initiated: October 07, 2014
Classification: Class II
Status: Terminated
Recalling firm: Mako Surgical Corporation
Quantity: Total 404

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

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

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

Code information

Part Number: 112710, Lot Numbers: 120027, 120041, 120052, 120074, 120076 and 120075.

Distribution pattern

Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.

device · product 2 of 3

RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

Z-0829-2015

Recall number: Z-0829-2015
Initiated: October 07, 2014
Classification: Class II
Status: Terminated
Recalling firm: Mako Surgical Corporation
Quantity: Total 404

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

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

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

Code information

Part Number: 207390, Lot Numbers: 21948201, 21948302, 21948403, 21948501, 21948605 and 21948704.

Distribution pattern

Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.

device · product 3 of 3

RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

Z-0830-2015

Recall number: Z-0830-2015
Initiated: October 07, 2014
Classification: Class II
Status: Terminated
Recalling firm: Mako Surgical Corporation
Quantity: Total 404

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

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

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

Code information

Part Number: 206276, Lot Numbers: 6011112, 6020114, 6030314, 6030712, 6110612 and E453704.

Distribution pattern

Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.