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Terminated

Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T

FDA Recall Z-1172-2019 · Posted None

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeHSN
Date Initiated2019-03-08
Date Terminated2020-05-15
Product Quantity2029

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

Firm 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: [email protected]

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182878Integra Salto Total Ankle SystemAscension Orthopedics · 2018-12-18K153452Salto XT, Salto TalarisTornier S.A.S. · 2016-08-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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