Class 2 Device Recall Salto Talaris Total Ankle Prosthesis

• Date Initiated by Firm: March 08, 2019
• Create Date: April 16, 2019
• Recall Status: Terminated on May 15, 2020
• Recall Number: Z-1157-2019
• Recall Event ID: 82377
• 510(K)Number: K060544 K090076 K130533
• Product Classification: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer - Product Code HSN
• Product: Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T
• Code Information: 180075 181348
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: Customer Service; 800-654-2873
• Manufacturer 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
• FDA Determined 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 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
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HSN and Original Applicant = TORNIER; 510(K)s with Product Code = HSN and Original Applicant = Tornier SAS