CLASS II ONGOING Device recall · Reported 27 Mar 2024 · FDA Enforcement Report
Assembly, Array Guide Tmini recalled by Think Surgical
Think Surgical is recalling Assembly, Array Guide Tmini, distributed nationwide in the US. The recall was initiated on 12 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1318-2024
- FDA event ID
- 94086
- Recalling firm
- Think Surgical, Fremont, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Feb 2024
- FDA classified
- 20 Mar 2024
- Reported
- 27 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 12 Feb 2024 | Recall initiated by company | |
| 20 Mar 2024 | Classified by FDA | +37 days |
| 27 Mar 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.
Product as listed by the FDA
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Where it was distributed
US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
Questions about this recall
Why was it recalled?
There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.
Which lots are affected?
UDI-DI: M9461091010. Lot Numbers: 2316701, 2232601, 23030, 2228501, 2327802, 22152
Where was it sold?
US Nationwide distribution in the states of AL, OH, NV, TX, UT, CA, MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Think Surgical
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tmini Femur Tracking Array recalled by Think Surgical | Think Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Cutter, Flat, ¿ For use only with the TCAT Computer-Assisted Tool recalled | Think Surgical | Other | 4 states |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |