Recall Z-1157-2019 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Integra LifeSciences Corp.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T
| Date | Mar 8, 2019 |
| Status | Terminated |
| 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 |
| Root cause | Other |
| Action | On March 8, 2019, the firm notified affected customers and distributors of the product issue via Urgent Medical Device Correction letter. The letter advised customers that the incorrect metallic coating material symbol had been printed on the implants labeling. Customers were asked to do the following: Please examine your inventory to determine if you have any Salto Talaris Total Ankle Prosthesis implants and/or Integra XT Revision Total Ankle Replacement System implants. Customers: 1. If you do have any impacted lots of Salto Talaris Total Ankle Prosthesis implants and/or Integra XT Total |
| Quantity | 2029 |
| Distribution | 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. |
| FDA record | Open on fda.gov |