CLASS II Device recall · Reported 24 Apr 2019 · FDA Enforcement Report

Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right recalled

Integra LifeSciences is recalling Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T, distributed in 26 states. The recall was initiated on 8 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes182853 182854 183344

Quantity recalled2029

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1168-2019
FDA event ID: 82377
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 8 Mar 2019
FDA classified: 16 Apr 2019
Reported: 24 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Mar 2019	Recall initiated by company
16 Apr 2019	Classified by FDA	+39 days
24 Apr 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T

Where it was distributed

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.

Alabama California Connecticut Florida Georgia Hawaii Iowa Idaho Kansas Kentucky Maryland Michigan Missouri Montana North Carolina Nebraska New Jersey New Mexico New York Ohio

Questions about this recall

Why was it 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

Which lots are affected?

182853 182854 183344

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

25 other products · FDA event 82377

This product is part of a recall event; the main page for the event is Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right recalled.

Reported	Class	Recall	Company	Reason	Where
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Salto Talaris Tibial Total Ankle Prosthesis Tray recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Salto Talaris Tibial Total Ankle Prosthesis Tray recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Salto Talaris Tibial Total Ankle Prosthesis Tray recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Salto Talaris Tibial Total Ankle Prosthesis Tray recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Salto Talaris Tibial Total Ankle Prosthesis Tray recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Salto Talaris Tibial Total Ankle Prosthesis Tray recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right recalled	Integra LifeSciences	Other	26 states
24 Apr 2019	CLASS II	Salto Talaris, Tibial Total Ankle Prosthesis Tray recalled	Integra LifeSciences	Other	26 states

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