Salto Talaris Tibial Total Ankle Prosthesis Tray — Class II medical device recall Z-1156-2019
Terminated recall by Integra LifeSciences Corp., reported 2019-04-24, distributed in AL, CA, CT, FL, GA, HI, IA, ID…. The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating ma
| Recall number | Z-1156-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2019-03-08 |
| Classified | 2019-04-16 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-05-15 |
| Distributed | AL, CA, CT, FL, GA, HI, IA, ID, KS, KY, MD, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, TX, VA, WA, WI |
| Quantity | 2,029 |
| Reason classes | labeling |
| Model numbers | LJU212T |
Product
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T
Reason for recall
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
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-1156-2019. 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.