Health product recall

Hi-Tec Implants Dental Devices

Brand(s)
Hi Tec Implants Ltd.
Last updated

Summary

Product
Hi-Tec Implants Dental Devices
Issue
Medical devices - Unauthorised device
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Pilot Drills

All lots.

PD
PD-EX.IR

Titanium Angulated Abutment - Screw In

All lots.

W-ANA-15-E1
W-ANA-15-E2
RV-ANA-15
W-ANA15
W-ANA25

Metal Housing

All lots.

LH
MH

Abutment Screw

All lots.

AS-S
LGI-SCREW 6.0
AS-L
LGI-SCREW 4.3
LGI-SCREW 5.0
AS-M

External Irrigation Drills

All lots.

XTD-EX.IR
RTD-EX.IR
RB-EX.IR

Extended Angulation Processing Package

All lots.

EAPP

Counter Sink Drill

All lots.

CSD

Implant For Ball Attachment

All lots.

TRX-TP-2.4
TRX-BA 2.8-10
TRX-TP-BA

Trx Titanium Thread Implant

All lots.

TRX-OP 3.7
TRX-OP 4.5
TRX-OP 2.8

Abutment - Sleeve

All lots.

X-HPB

Titanium Angulated Abutment - Two Piece

All lots.

ACA-E-2
NV-ACA
SL-PRZ-R
ACA-E-3
NL-PRZ
RV-ACA
W-PRZ
ACA-S
NL-TA-R
NV-PRZ
SL-ACA-3.5
SL-ACA-4.5
SL-PRZ
W-ACA-E-4
WV-PRZ
NL-TA
NL-ACA-1.5
NL-ACA-4.5
SL-ACA-1.5
ACA-E-4
PRZ
RV-PRZ-R
SL-ACA-2.5
SL-TA
W-ACA-E-2
WV-PRZ-R
ACA
ACA-E-1
NV-PRZ-R
SL-TA-R
W-ACA-E-3
NL-ACA-2.5
NL-ACA-3.5
NL-PRZ-R
RV-PRZ
WV-ACA

Hi-Tec Surgical Instruments

All lots.

ANL
ATL
BNL
DCP
DRPP
FSD
FSD-EX.IR
GTI-10-SR
GTI-11.5-SR
GTI-13-SR
GTI-8-SR
HC3
HC-3-P
HC-5
IL
ILD
LGI 3.0
LGI 3.5
LGI 4.3
LGI 5
LGI 6
LGI PLUS 3.5
LGI PLUS 4.3
LGI PLUS 5
LGI PLUS 6
LGI-ANA
LGP-SUR-KIT
L-IL
LIT-C
LIT-L
LIT-M
LIT-S
MU-CL
MU-IT
MU-IT-Q
MU-TB
NC

Hi-Tec Surgical Instruments

All lots.

NC-D-PINK
NC-D-PUR
NC-E-CLR
NC-E-PINK
NC-E-PUR
NC-E-YEL
NL-FS
NL-HC-3
NL-HC-5
NL-HC-F
NL-IL
NL-LIT-C
NL-LIT-L
NL-SCAN-S
NTI-10-SR
NTI-13-SR
NTI-8-SR
NV-LIT-S
O-RING-FT
O-RING-LIT
ORT
PT
RPA
RPA 15
RPA 25
SHT-C
SHT-L
SHT-S
S-IL-D
SL-AS-S
SL-FT-L
SL-FT-S
SL-HC-3
SL-HC-5
SL-HC-F

Hi-Tec Surgical Instruments

All lots.

SL-IL
SL-LIT-C
SL-LIT-L
SL-LIT-S
SL-PRN
SL-SCAN-S
SLT-08-SR
SLT-10-SR
SLT-11.5-SR
SLT-13-SR
S-PRN
S-PRN-R
S-SCAN-L
S-SCAN-S
ST-LGP-ANA
STP-FSD-10
STP-FSD-11
STP-NTD-11
STP-NTD-S
STP-PD-10
STP-PD-11
STP-PD-13
STP-PD-8
STP-STD-S
ST-SUR-KIT
ST-W-ANA
ST-W-HC-3
ST-W-HC-3-P
ST-W-HC-5
ST-W-HC-5-P
SUR.KIT
TIT-B
TIT-S
TRI-N
TRI-N-10-SR
TRI-N-13-SR
TRI-N-SR
V-AS
VRI 5

Hi-Tec Surgical Instruments

All lots.

W-IL
W-PRN
W-PRN-R
W-SCAN-S
WTI-10-SR
WTI-11.5-SR
WTI-13-SR
WTI-8-SR
XOT-L
XOT-S
XTL
XTR

Nylon Cap

All lots.

NC
NC-D-PINK
NC-E-CLR
NC-E-PINK
NC-E-YEL
NC-D-PUR
NC-E-PUR

Abutment

All lots.

S-SCAN-L
NL-SCAN-S
RPA
S-SCAN-S
W-SCAN-S
RPA 15
SL-SCAN-S
RPA 25

Titanium Base

All lots.

S-PRN-R
SL-PRN
W-PRN-R
S-PRN
MU-TB
W-PRN

Implant For Cemented Restoration

All lots.

TRI-N
TRI-N-13-SR
TRI-N-10-SR
TRI-N-SR

Titanium Screws

All lots.

SL-AS-S
NL-FS
V-AS

Implant Analog

All lots.

ATL
BNL
IL
ILD
W-IL
SL-IL
ANL
NL-IL
L-IL
MU-CL
S-IL-D

2nd Stage Twist Drills

All lots.

FSD
FSD-EX.IR

Self Thread Titanium Implants

All lots.

GTI-8-SR
SLT-13-SR
LGI PLUS 5
SLT-08-SR
SLT-11.5-SR
WTI-13-SR
GTI-13-SR
LGI 3.0
LGI PLUS 6
NTI-10-SR
NTI-13-SR
NTI-8-SR
LGI 4.3
WTI-8-SR
LGI 5
LGI PLUS 3.5
WTI-10-SR
WTI-11.5-SR
LGI 3.5
GTI-10-SR
GTI-11.5-SR
LGI 6
LGI PLUS 4.3
SLT-10-SR
VRI 5

Healing Caps

All lots.

ST-W-HC-5
ST-W-HC-5-P
LGI-ANA
ST-W-HC-3
HC3
ST-W-ANA
NL-HC-F
ST-W-HC-3-P
HC-5
SL-HC-3
SL-HC-5
SL-HC-F
HC-3-P
NL-HC-3
NL-HC-5
ST-LGP-ANA

Titanium Angulated Abutment

All lots.

SL-ANA-1.5
S-MU-3
S-MU-4
SL-ANA-2.5
MU-AAT
NL-ANA-1.5
NL-MU-1
NL-AAT
NL-ANA-2.5
NL-MU-2
NL-MU-4
NL-MU-17
NL-MU-3
S-MU-1
S-MU-17
S-MU-30
SL-MU-2
NL-MU-30
S-MU-2
ST-LGP-ANA

Titanium Angualted Abutment - Over Denture

All lots.

BBA-L-1
BBA-6
BBA-L-2
SL-BBA-4
W-BBA-L-1
W-BBA-L-4
BBA-L-3
SL-BBA-2
BBA-2
BBA-4
TP-BA-0.5
BBA-L-5
RV-BBA-2
X-BBA
BBA-0.5
NL-BBA-4
SL-BBA-6
TP-BA-1.5
NL-BBA-2
NL-BBA-6
TP-SCA
W-BBA-L-5
BBA-L-4
W-BBA-L-2
W-BBA-L-3
X-SCA

Impression Transfer

All lots.

LOC-AAT
RV-AAT
AAT
WV-AAT
NV-AAT
AAT-L
NV-AAT-L
WV-AAT-L
SL-AAT-L
W-AAT
W-AAT-L
NL-AAT-L
RV-AAT-L

Final Drills

All lots.

STD
WTD
NTD-EX.IR
NTD
STD-EX.IR
GTD-EX.IR
WTD-EX,IR
GTD

Castable Abutment

All lots.

SL-PCA
PGA
W-PCA
NL-PGA
SL-PGA
NL-PCA
W-PGA

Angulated Cap

All lots.

NL-PRN

Issue

Hi-Tec Implants doesn't have a valid Health Canada license for their medical devices of class II and III as of Dec 7 2020. The list of devices is non-exhaustive; no devices manufactured by Hi-Tec Implants are licensed at the time of this recall.

Recall start date: February 17, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies

Hi Tec Implants Ltd.

20 Galgalei Plada Street, Herzlia, Israel, 4672220

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73467

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