Device product
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T
Z-1153-2019
Product summary
- Event
- Event 82377
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2029
- Official record key
device-enforcement:Z-1153-2019
Official wording
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
Code information: 181155 182900
Distribution pattern: Distributors in 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, and WI.
Derived failure modes
-
Unknown
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