FDA Device recall Z-1162-2019
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
- FDA Device
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T by Integra Lifesciences, citing 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) an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1162-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-08 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Integra Lifesciences |
| Distribution | 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 |
Product
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
Reason
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
Identifiers
| code_info | 180079 181349 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1162-2019%22
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