Integra LifeSciences Corp.: Medical Device Recall in 2019 - (Recall #: Z-1160-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T

Product Classification:

Class II

Date Initiated: March 8, 2019

Date Posted: April 24, 2019

Recall Number: Z-1160-2019

Event ID: 82377

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

Status: Terminated

Product Quantity: 2029

Code Information:

180751 180893 181149 181150 181151 185084 180894

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.

Voluntary or Mandated:

Voluntary: Firm initiated