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Incident · Recall

Stryker Mako bone-registration accuracy recall (Class II, 2022)

Stryker issued a voluntary field safety corrective action for the Mako SmartRobotics system relating to potential bone surface registration inaccuracies under specific intraoperative conditions. Affected units received software update. FDA classified as Class II recall. Filed in FDA enforcement reports as recall Z-0512-2023 (initiated 2022).

Occurred 2022-07-01 · Stryker Mako SmartRobotics · Stryker · Surgical robots

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Track Stryker Mako bone-registration accuracy recall (Class II, 2022)

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Stryker&productdescriptiontxt=Mako&postdatefrom=01/01/2017&postdateto=12/31/2026&PAGENUM=100

Common questions

What happened in Stryker Mako bone-registration accuracy recall (Class II, 2022)?
Stryker issued a voluntary field safety corrective action for the Mako SmartRobotics system relating to potential bone surface registration inaccuracies under specific intraoperative conditions. Affected units received software update. FDA classified as Class II recall. Filed in FDA enforcement reports as recall Z-0512-2023 (initiated 2022).
When did this incident occur?
The incident is recorded as occurring on July 1, 2022 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Stryker Mako bone-registration accuracy recall (Class II, 2022)?
Stryker Mako SmartRobotics by Stryker is the recorded robot involved in this incident.
Has anyone responded to Stryker Mako bone-registration accuracy recall (Class II, 2022)?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Stryker Mako bone-registration accuracy recall (Class II, 2022)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Stryker Mako bone-registration accuracy recall (Class II, 2022).

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Canonical ID 46e5eb27-ba9d-4cab-839c-51793dcd3e0f