Integra LifeSciences Corp.: Medical Device Recall in 2019 - (Recall #: Z-1170-2019)

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:

Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T

Product Classification:

Class II

Date Initiated: March 8, 2019

Date Posted: April 24, 2019

Recall Number: Z-1170-2019

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:

182857 182858 183345 183346

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