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Incident · Recall

THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment

THINK Surgical initiated a recall (Z-2716-2026) of TMINI Femur and Tibia Tracking Arrays (REF 109003/109004) because the knob on the tracking array may loosen, causing potential misalignment that could result in incorrect positional information communicated to the TMINI Miniature Robotic System. There have been 11 complaints regarding loose tracking arrays. Customers were instructed to inspect arrays before each use and return loose units.

Occurred 2026-05-08 · THINK Surgical · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
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Sources (1)

  1. FDA · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99219 · 2026-07-09

Status history

  • Active · 2026-08-17 · agent:recon

Common questions

What happened in THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment?
THINK Surgical initiated a recall (Z-2716-2026) of TMINI Femur and Tibia Tracking Arrays (REF 109003/109004) because the knob on the tracking array may loosen, causing potential misalignment that could result in incorrect positional information communicated to the TMINI Miniature Robotic System. There have been 11 complaints regarding loose tracking arrays. Customers were instructed to inspect arrays before each use and return loose units.
When did this incident occur?
The incident is recorded as occurring on May 8, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment?
The incident is recorded as involving THINK Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment?
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 THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-08-17

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-17

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 THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment.

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Canonical ID 333fc2ae-2b75-4198-a80c-004d3a2d0a2d