Hi-Tec Implants Dental Devices
Brand(s)
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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