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Lower risk Medical device recall · FDA · Published March 8, 2019

Integra Talar Dome Ankle Prosthesis Recall: Incorrect Metal Coating Labeling

Integra LifeSciences recalls specific Talar Dome Total Ankle Prostheses due to incorrect metal coating labeling on implant labels and instructions. Affected units may have safety risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1167-2019Medical deviceIntegra LifeSciences ›
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Contact the company

Recalling firmIntegra LifeSciences Corp.311 Enterprise Dr · Plainsboro, NJ 08536-3344
✎ GovInfoNow plain-language explainer

Integra LifeSciences is recalling certain Talar Dome Total Ankle Prostheses because the labels and instructions list an incorrect metal coating material symbol. This could lead to confusion about the implant's composition, though serious injury risks are not described in the recall. Read more at govinfonow.com/recall/68859-integra-talar-dome-ankle-prosthesis-recall-incorrect-metal-coating-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/68859-integra-talar-dome-ankle-prosthesis-recall-incorrect-metal-coating-labeling · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1167-2019

Cite this page

“Integra Talar Dome Ankle Prosthesis Recall: Incorrect Metal Coating Labeling.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68859-integra-talar-dome-ankle-prosthesis-recall-incorrect-metal-coating-labeling. Based on FDA recall #Z-1167-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1167-2019%22&limit=1).

Integra LifeSciences Corp. recalled the Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right (Product No. LJU813T) due to incorrect metallic coating material symbols on labels, the FDA said on March 8, 2019.

How to tell if you have it

  • Brand: Integra LifeSciences
  • Product: Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right
  • Product No.: LJU813T
  • Lot codes: 180078, 182903, 183670, 190799
  • Quantity: 2029 units

The hazard

The Salto Talaris and Integra XT Revision implant labeling listed an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU.

Context

GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since Aug. 18, 2017. Other recent recalls of similar products include the Integra AURORA Surgiscope System Recall (Feb. 6, 2025), the MediHoney Wound Dressing Gel Recall (Jan. 10, 2025), and the Integra LifeSciences CODMAN CERTAS Plus Valve Recall (Dec. 16, 2024). Other recent recalls of similar products include the EMPOWR 3D KNEE Implants Have Incorrect Labeling - Recall Notice (Jan. 15, 2026), the DT MedTech Hintermann Talar Implant Left Size 2: Incorrect Left/Right Labeling (March 24, 2026), and the Straumann Custom Abutment AS Ti Recall (March 17, 2026).

How to tell if you have this one

Check for the Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right with Product No. LJU813T. The product was sold with serial numbers 180078, 182903, 183670, and 190799.

  • Brand
    Integra LifeSciences
  • Category
    Medical device
FDA recall event · 26 products

All 26 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • 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.
Recall numberProduct, codes & lots
Z-1150-2019Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T; 180072 181145 184085 184086
Z-1151-2019Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T; 181146 181718
Z-1152-2019Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T; 180073 181259 182899
Z-1153-2019Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T; 181155 182900
Z-1154-2019Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T; 180074 181260 182901 184538
Z-1155-2019Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T; 180859
Z-1156-2019Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T; 181147 181719 181720 183669
Z-1157-2019Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T; 180075 181348
Z-1158-2019Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T; 181148
Z-1159-2019Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T; 180750 180860 180861 180892 181432
Z-1160-2019Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T; 180751 180893 181149 181150 181151 185084 180894
Z-1161-2019Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T; 180894 181152
Z-1162-2019Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T; 180079 181349
Z-1163-2019Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T; 180080 182904 183671 184878
Z-1164-2019Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T; 180081
Z-1165-2019Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T; 180076 180082 185085
Z-1166-2019Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T; 180077 182902 185086
Z-1167-2019Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T; 180078 182903 183670 190799
Z-1168-2019Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T; 182853 182854 183344
Z-1169-2019Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T; 182855 182856 183397
Z-1170-2019Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T; 182857 182858 183345 183346
Z-1171-2019Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T; 182859 183347 183348
Z-1172-2019Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T; 183349
Z-1173-2019Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T; 182860 182861 183350 183351
Z-1174-2019Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T; 182862 183352 183353
Z-1175-2019Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T; 182863 182864 183354
Based on the official FDA remedy

What to do — step by step

  1. Check Label Details

    Review the metal coating material symbol on the implant's box and inner pouch labels for accuracy.

Where it went and when

Where it was distributed

Distributed in 26 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: yesNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Connecticut, Florida, Georgia, Hawaii, Idaho, Iowa, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

1. Firm started the recall: Mar 8, 201912. FDA classified it Class II: Apr 16, 201923. Published in FDA’s Enforcement Report: Apr 24, 201934. FDA terminated the recall: May 15, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

The recall does not describe any safety risks or injuries. The issue is labeling confusion, not a physical hazard.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1167-2019 (March 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1167-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA