Food, drugs, devices › Integra LifeSciences Corp.

Device recall: Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T

FDA enforcement event 82377 · Class II · initiated 8 Mar 2019 · status Terminated · terminated 15 May 2020

DeviceVoluntary: Firm initiated26 product recordsPlainsboro, NJ

Integra LifeSciences Corp. (Plainsboro, NJ) initiated this device recall on 8 Mar 2019; FDA lists 26 product records under event 82377, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 15 May 2020. Initiation: voluntary: firm initiated. Integra LifeSciences Corp. has 79 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Integra LifeSciences Corp., Plainsboro, NJ.

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"

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."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1150-2019	Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T	2029	Class II	Terminated	24 Apr 2019
Z-1151-2019	Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T	2029	Class II	Terminated	24 Apr 2019
Z-1152-2019	Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T	2029	Class II	Terminated	24 Apr 2019
Z-1153-2019	Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T	2029	Class II	Terminated	24 Apr 2019
Z-1154-2019	Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T	2029	Class II	Terminated	24 Apr 2019
Z-1155-2019	Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T	2029	Class II	Terminated	24 Apr 2019
Z-1156-2019	Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T	2029	Class II	Terminated	24 Apr 2019
Z-1157-2019	Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T	2029	Class II	Terminated	24 Apr 2019
Z-1158-2019	Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T	2029	Class II	Terminated	24 Apr 2019
Z-1159-2019	Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T	2029	Class II	Terminated	24 Apr 2019
Z-1160-2019	Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T	2029	Class II	Terminated	24 Apr 2019
Z-1161-2019	Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T	2029	Class II	Terminated	24 Apr 2019
Z-1162-2019	Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T	2029	Class II	Terminated	24 Apr 2019
Z-1163-2019	Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T	2029	Class II	Terminated	24 Apr 2019
Z-1164-2019	Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T	2029	Class II	Terminated	24 Apr 2019
Z-1165-2019	Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T	2029	Class II	Terminated	24 Apr 2019
Z-1166-2019	Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T	2029	Class II	Terminated	24 Apr 2019
Z-1167-2019	Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T	2029	Class II	Terminated	24 Apr 2019
Z-1168-2019	Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T	2029	Class II	Terminated	24 Apr 2019
Z-1169-2019	Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T	2029	Class II	Terminated	24 Apr 2019
Z-1170-2019	Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T	2029	Class II	Terminated	24 Apr 2019
Z-1171-2019	Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T	2029	Class II	Terminated	24 Apr 2019
Z-1172-2019	Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T	2029	Class II	Terminated	24 Apr 2019
Z-1173-2019	Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T	2029	Class II	Terminated	24 Apr 2019
Z-1174-2019	Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T	2029	Class II	Terminated	24 Apr 2019
Z-1175-2019	Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T	2029	Class II	Terminated	24 Apr 2019

Context

88%of 2019 device events are Class II968 events that year

26product records in this eventfirm median: 1

79events on this register for the firm

Other enforcement events for Integra LifeSciences Corp.

Initiated	Product (first record)	Type	Class	Records
6 Feb 2025	AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Produ	Device	Class II	1
10 Jan 2025	Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Versi	Device	Class II	1
16 Dec 2024	CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides con	Device	Class II	3
26 Sep 2024	Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694	Device	Class II	1
20 Sep 2024	MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTT	Device	Class II	22
13 Sep 2024	MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515)	Device	Class II	1
9 Jul 2024	TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with t	Device	Class II	1
7 Jun 2024	AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.	Device	Class II	1
29 May 2024	CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification a	Device	Class II	1
7 May 2024	CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dim	Device	Class II	3

All 79 events for Integra LifeSciences Corp.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.