CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report
Square Driver recalled by Think Surgical
Think Surgical is recalling Square Driver, distributed nationwide in the US. The recall was initiated on 20 Aug 2026 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-0192-2027
- FDA event ID
- 99870
- Recalling firm
- Think Surgical, Fremont, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Aug 2026
- FDA classified
- 16 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 20 Aug 2026 | Recall initiated by company | |
| 16 Oct 2026 | Classified by FDA | +57 days |
| 28 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
Product as listed by the FDA
Think Surgical Square Driver REF: 109126
Where it was distributed
US Nationwide distribution in the states of NY and DE.
Questions about this recall
Why was it recalled?
Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
Which lots are affected?
Lot: 25356/Primary DI: M9461091260
Where was it sold?
US Nationwide distribution in the states of NY and DE.
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 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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