Think Surgical TMINI Tracking Arrays Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Think Surgical, Inc. is recalling 360 TMINI Femur and Tibia Tracking Arrays due to a manufacturing issue that may cause misalignment.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Think Surgical, Inc. initiated a voluntary recall of certain TMINI tracking arrays due to a manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Which Products Are Affected
The recall affects 360 devices distributed nationwide in the United States in the states of AZ, CA, DE, FL, IA, KS, LA, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, TX, UT, VA, and WA. Affected products include:
- TMINI Femur Tracking Array REF 109003 (UDI-DI code: M9461090030)
- TMINI Tibia Tracking Array REF 109004 (UDI-DI code: M9461090040)
The TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. Recall number: Z-2716-2026. Classification: Class II.
What You Should Do
Consumers should contact Think Surgical, Inc. for additional information regarding the recall.
Why This Matters
The recall involves devices used in total knee replacement surgeries across multiple states, with 360 units affected.
Source
FDA recall number Z-2716-2026; recalling firm Think Surgical, Inc., Fremont, CA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,143 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.