Public recall detail

Hi-Tec Implants Dental Devices

2023-04-06

medium
Recall Safety notice
Quick summary

Quick summary: Hi-Tec Implants Dental Devices. Date: 2023-04-06.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Hi-Tec Implants Dental Devices. Date: 2023-04-06.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandHi Tec Implants Ltd.
ProductHi-Tec Implants Dental Devices
IssueMedical devices - Unauthorised device
Recall classType II
IdentificationRA-73467

Affected products

ProductPilot Drills
LotAll lots.
ModelPD PD-EX.IR
Serial numberAll lots.
DescriptionPilot Drills
ProductTitanium Angulated Abutment - Screw In
LotAll lots.
ModelW-ANA-15-E1 W-ANA-15-E2 RV-ANA-15 W-ANA15 W-ANA25
Serial numberAll lots.
DescriptionTitanium Angulated Abutment - Screw In
ProductMetal Housing
LotAll lots.
ModelLH MH
Serial numberAll lots.
DescriptionMetal Housing
ProductAbutment Screw
LotAll lots.
ModelAS-S LGI-SCREW 6.0 AS-L LGI-SCREW 4.3 LGI-SCREW 5.0 AS-M
Serial numberAll lots.
DescriptionAbutment Screw
ProductExternal Irrigation Drills
LotAll lots.
ModelXTD-EX.IR RTD-EX.IR RB-EX.IR
Serial numberAll lots.
DescriptionExternal Irrigation Drills
ProductExtended Angulation Processing Package
LotAll lots.
ModelEAPP
Serial numberAll lots.
DescriptionExtended Angulation Processing Package
ProductCounter Sink Drill
LotAll lots.
ModelCSD
Serial numberAll lots.
DescriptionCounter Sink Drill
ProductImplant For Ball Attachment
LotAll lots.
ModelTRX-TP-2.4 TRX-BA 2.8-10 TRX-TP-BA
Serial numberAll lots.
DescriptionImplant For Ball Attachment
ProductTrx Titanium Thread Implant
LotAll lots.
ModelTRX-OP 3.7 TRX-OP 4.5 TRX-OP 2.8
Serial numberAll lots.
DescriptionTrx Titanium Thread Implant
ProductAbutment - Sleeve
LotAll lots.
ModelX-HPB
Serial numberAll lots.
DescriptionAbutment - Sleeve
ProductTitanium Angulated Abutment - Two Piece
LotAll lots.
ModelACA-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
Serial numberAll lots.
DescriptionTitanium Angulated Abutment - Two Piece
ProductHi-Tec Surgical Instruments
LotAll lots.
ModelANL 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
Serial numberAll lots.
DescriptionHi-Tec Surgical Instruments
ProductHi-Tec Surgical Instruments
LotAll lots.
ModelNC-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
Serial numberAll lots.
DescriptionHi-Tec Surgical Instruments
ProductHi-Tec Surgical Instruments
LotAll lots.
ModelSL-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
Serial numberAll lots.
DescriptionHi-Tec Surgical Instruments
ProductHi-Tec Surgical Instruments
LotAll lots.
ModelW-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
Serial numberAll lots.
DescriptionHi-Tec Surgical Instruments
ProductNylon Cap
LotAll lots.
ModelNC NC-D-PINK NC-E-CLR NC-E-PINK NC-E-YEL NC-D-PUR NC-E-PUR
Serial numberAll lots.
DescriptionNylon Cap
ProductAbutment
LotAll lots.
ModelS-SCAN-L NL-SCAN-S RPA S-SCAN-S W-SCAN-S RPA 15 SL-SCAN-S RPA 25
Serial numberAll lots.
DescriptionAbutment
ProductTitanium Base
LotAll lots.
ModelS-PRN-R SL-PRN W-PRN-R S-PRN MU-TB W-PRN
Serial numberAll lots.
DescriptionTitanium Base
ProductImplant For Cemented Restoration
LotAll lots.
ModelTRI-N TRI-N-13-SR TRI-N-10-SR TRI-N-SR
Serial numberAll lots.
DescriptionImplant For Cemented Restoration
ProductTitanium Screws
LotAll lots.
ModelSL-AS-S NL-FS V-AS
Serial numberAll lots.
DescriptionTitanium Screws
ProductImplant Analog
LotAll lots.
ModelATL BNL IL ILD W-IL SL-IL ANL NL-IL L-IL MU-CL S-IL-D
Serial numberAll lots.
DescriptionImplant Analog
Product2nd Stage Twist Drills
LotAll lots.
ModelFSD FSD-EX.IR
Serial numberAll lots.
Description2nd Stage Twist Drills
ProductSelf Thread Titanium Implants
LotAll lots.
ModelGTI-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
Serial numberAll lots.
DescriptionSelf Thread Titanium Implants
ProductHealing Caps
LotAll lots.
ModelST-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
Serial numberAll lots.
DescriptionHealing Caps
ProductTitanium Angulated Abutment
LotAll lots.
ModelSL-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
Serial numberAll lots.
DescriptionTitanium Angulated Abutment
ProductTitanium Angualted Abutment - Over Denture
LotAll lots.
ModelBBA-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
Serial numberAll lots.
DescriptionTitanium Angualted Abutment - Over Denture
ProductImpression Transfer
LotAll lots.
ModelLOC-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
Serial numberAll lots.
DescriptionImpression Transfer
ProductFinal Drills
LotAll lots.
ModelSTD WTD NTD-EX.IR NTD STD-EX.IR GTD-EX.IR WTD-EX,IR GTD
Serial numberAll lots.
DescriptionFinal Drills
ProductCastable Abutment
LotAll lots.
ModelSL-PCA PGA W-PCA NL-PGA SL-PGA NL-PCA W-PGA
Serial numberAll lots.
DescriptionCastable Abutment
ProductAngulated Cap
LotAll lots.
ModelNL-PRN
Serial numberAll lots.
DescriptionAngulated Cap

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Dental
CompaniesHi Tec Implants Ltd. 20 Galgalei Plada Street, Herzlia, Israel, 4672220
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73467
Background{}
CompaniesHi Tec Implants Ltd. 20 Galgalei Plada Street, Herzlia, Israel, 4672220
AudiencesHealthcare
Source updated2023-04-06

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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