Salto Talaris Tibial Guide — Class II medical device recall Z-2465-2015
Terminated recall by Tornier, Inc, reported 2015-09-02, distributed in CA, ME, NC, PA, TX. Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a comp
| Recall number | Z-2465-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2015-08-06 |
| Classified | 2015-08-26 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2016-04-08 |
| Distributed | CA, ME, NC, PA, TX |
| Quantity | 5 |
| Lot numbers | 14F005 |
| Model numbers | MJU333, YKAL11 |
Product
Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
Reason for recall
Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide.
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-2465-2015. 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.