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

Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T recalled

Integra LifeSciences is recalling Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T, 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 codes180894 181152

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-1161-2019
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: Hip & Knee Implants

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

Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T

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

Is Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T recalled?

Yes. Integra LifeSciences recalled Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T on 8 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1161-2019.

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?

180894 181152

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

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Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Nitrosamine Impurity	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide