FDA recall Z-1165-2019

Product

Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T

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

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.

Key facts

Status

Terminated

Initiation date

2019-03-08

Report date

2019-04-24

Termination date

2020-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1165-2019