—#171504

Product

Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T

FDA product code: HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K153452, K182878
Affected lot / code info: 182860 182861 183350 183351

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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 If you have any impacted lots of Salto Talaris Total Ankle Prosthesis implants and/or Integra XT Total Revision Ankle Replacement System implants, please be aware the correct material symbol is CP Ti. The IFU containing the correct material symbol can be accessed at the link below. Product removal is not required. Distributors: I1. f you have any impacted lots of Salto Talaris Total Ankle Prosthesis implants and/or Integra XT Total Revision Ankle Replacement System implants, please be aware the correct material symbol is CP Ti. The IFU containing the correct material symbol can be accessed at the link below. Product removal is not required. "2. We also kindly ask that you provide this letter to impacted customers who may have affected products. IFU Link: Integra XT: https://www.integralife.com/file/general/1551465297.pdf Salto Talaris: https://www.integralife.com/file/general/1546543287.pdf Customers and distributors were asked to complete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

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.

Timeline

Recall initiated: 2019-03-08
Terminated: 2020-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171504. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.