THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment
[RECALL]May 8, 2026 · THINK Surgical · THINK Surgical TMINI · Fremont
Failure Mode
RECALL
Event Date
May 8, 2026
Primary Entity
THINK Surgical
Robotic Platform
THINK Surgical TMINI
Jurisdiction / Location
Fremont
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99219
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99219
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Details
Incident Context & FAQ
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.
What robot was involved in THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment?
THINK Surgical TMINI by THINK Surgical is the recorded robot involved in this incident at Fremont.
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.