Assembly — Class II medical device recall Z-1318-2024
Ongoing recall by Think Surgical, Inc., reported 2024-03-27, distributed nationwide. There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array g
| Recall number | Z-1318-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Think Surgical, Inc., Fremont, CA, United States |
| Recall initiated | 2024-02-12 |
| Classified | 2024-03-20 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 16 |
| Lot numbers | 22152, 2228501, 2232601, 23030, 2316701, 2327802 |
| Model numbers | 109101 |
Product
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1318-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.