FDA Device Recall Z-0014-2022: Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0014-2022.

Recall Res Number

Z-0014-2022

Recalling Firm / Manufacturer

Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel

FEI Number

3009161350

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2021-07-26

Date Posted

N/A

Date Terminated

2023-09-21

Product Code

NDP

Event Number

88576

Product Quantity

354

Product Description Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Reason for Recall Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.

Action Details Impacted customers were contacted on July 26, 2021 via overnight delivery of written notification. The firm is replacing all components listed in the recall, purchased prior to 7/21/2021. Customers were asked to complete and return the provided product replacement form. A customer service representative will contact you to evaluate your inventory and to facilitate the exchange immediately. Please contact your Customer Service Department at 866-902-9272 for any questions.

Distribution Pattern US Nationwide distribution. No foreign distribution from US.

Code Information / Serial Numbers All lots manufactured prior to July 21, 2021.

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HADER Solutions & Distribution Ltd Registration: 3026401444 View Registration
Medentika GmbH Registration: 3026444199 View Registration
Riton 3D Technology Co., Ltd Registration: 3027303702 View Registration
SUZHOU LAIXIN 3D TECHNOLOGY CO.,LTD Registration: 3027508795 View Registration
Loyol New Material Suhzou Co.,Ltd. Registration: 3027520370 View Registration
MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. Registration: 3027526455 View Registration
OPEN IMPLANTS Registration: 3027595870 View Registration
INFINITUM ETA LTD. Registration: 3027665899 View Registration
ECLECTIC INC. Registration: 3029820793 View Registration
BES DEPOT, LLC Registration: 3029895607 View Registration
KAUL MEDIZINTECHNIK GMBH Registration: 3029933740 View Registration
PNUAdd Co., Ltd. Registration: 3029973772 View Registration
DMI TECHNOLOGY LLC Registration: 3030039110 View Registration
MegaGen Implant Co., Ltd. (Research Laboratories) Registration: 3030089802 View Registration
ONVET MEDICAL CANADA INC Registration: 3030126955 View Registration
APPLY LABWORK INC. Registration: 3030181318 View Registration
ATOMICA TECHNOLOGY, INC Registration: 3030228551 View Registration
Smyles Above Innovations, Inc Registration: 3030228577 View Registration
ORANGECAD MED GMBH Registration: 3030488649 View Registration
Amann Girrbach AG Registration: 3030515618 View Registration
DANTECH DIGITAL DENTAL SOLUTIONS PRIVATE LIMITED Registration: 3030516430 View Registration
ENDONEST MEDICAL SYSTEMS LLP Registration: 3030516433 View Registration
PENGBO (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD. Registration: 3030671632 View Registration
OSSEO PURE INC Registration: 3030863060 View Registration
GUIDED SMILE Registration: 3030896107 View Registration
BLUE ELEPHANT INC Registration: 3031025053 View Registration
SHANDONG HENGFENG KERUI MEDICAL EQUIPMENT CO., LTD Registration: 3031191035 View Registration
SHENZHEN DAZHOU MEDICAL TECHNOLOGY CO., LTD. Registration: 3031235905 View Registration
IMPLANT ATTACHMENTS LLC Registration: 3031303433 View Registration
IZENIMPLANT CO., LTD. Registration: 3031493119 View Registration
MOZO-GRAU SA Registration: 3031553803 View Registration
SHANGHAI LIONS INDUSTRIAL CO.,LTD. Registration: 3031582434 View Registration
Solventum US LLC Registration: 3031841433 View Registration
OSSTEM IMPLANT CO., LTD. Registration: 3031886796 View Registration
APOLLO IMPLANT COMPONENTS Sp. z o.o. Registration: 3032078590 View Registration
Solventum US LLC Registration: 3032163716 View Registration
AXIODENT INC. Registration: 3032312561 View Registration
ZEROS CO., LTD. Registration: 3032439351 View Registration
ZIMA INTERNATIONAL, INC. Registration: 3032802037 View Registration
FULL ARCH TECHNOLOGIES LTD Registration: 3033436335 View Registration
RDJ TOV IMPLANT LTD Registration: 3033524692 View Registration
PARAGON IMPLANT COMPANY, LLC Registration: 3033708818 View Registration
Straumann Manufacturing, Inc. Registration: 3033781108 View Registration
The American Angle, LLC Registration: 3034725654 View Registration
ALLONUS TECH CO., LTD. Registration: 3035532393 View Registration
BIOABUTMENT INC. Registration: 3035532394 View Registration
DIGITAL ARCHES INC. Registration: 3035983708 View Registration
Dentis Co.,Ltd Registration: 3036190511 View Registration
GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD Registration: 3036269993 View Registration
QUICKDENT DEVICES PRIVATE LIMITED Registration: 3036779616 View Registration
KLS MARTIN SE & CO. KG Registration: 3036795921 View Registration
LX PRECISION PORTUGAL, UNIPESSOAL, LDA Registration: 3038136479 View Registration
KTJ DENTAL LAB INC Registration: 3038181756 View Registration
Aidite (Shenzhen) Medical Technology Co., Ltd Registration: 3038195217 View Registration
SKY HKMC INTERNATIONAL LIMITED Registration: 3038290056 View Registration
INFINETAMED AG Registration: 3038549074 View Registration
TF NEW MATERIAL SCI AND TEC CO.,LTD Registration: 3038632739 View Registration
SMD DENTAL LABORATORY Registration: 3038715999 View Registration
XIAMEN XIANG JI PRECISION MACHINERY TECHNOLOGY CO., LTD Registration: 3039698130 View Registration
HUB BIOTECH CO., LTD. Registration: 3042200066 View Registration
AMG DENTAL LTD Registration: 3042227762 View Registration
SOLVENTUM US LLC Registration: 3042272797 View Registration
COVISION CO., LTD. Registration: 3042852773 View Registration
OSSEO MAX INC Registration: 3042927692 View Registration
SHINSAEGI MEDI-TECH CO., LTD. Registration: 3042969838 View Registration
DIMPLO Ltd. Registration: 3042971970 View Registration
GUANGDONG ZHILIANXING PRECISION TECHNOLOGY CO.,LTD. Registration: 3043105508 View Registration
HANGZHOU WISE MEDICAL DEVICE CO.,LTD Registration: 3043149181 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
ONE DAY DENTAL PARTNER Registration: 3043303267 View Registration
SURCAM MEDICAL DEVICES AND DEVELOPMENTS LTD Registration: 3043585140 View Registration
RP CONEXOES RESTAURADORAS LTDA Registration: 3043618669 View Registration
DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD. Registration: 3043648115 View Registration
PALAXA PRECISION LLC Registration: 3043841530 View Registration
MODERN DENTAL LABORATORY USA, LLC Registration: 3043842086 View Registration
Shanghai Jolly Industrial Co., Ltd. Registration: 3044150131 View Registration
XIAMEN ANTINSKY INDUSTRY CO., LTD Registration: 3044921218 View Registration
EDENTAL LAB CO., LTD Registration: 3045005836 View Registration
MEDICON, E.G. Registration: 8010099 View Registration
A. SCHWEICKHARDT GMBH & CO. KG Registration: 8010159 View Registration
STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration
GEBR. BRASSELER GMBH & CO. KG Registration: 8010468 View Registration
HAGER & MEISINGER GMBH Registration: 8010516 View Registration
Faulhaber Pinzetten KG Registration: 8010591 View Registration
Kohler Medizintechnik GmbH Registration: 8010732 View Registration
VOCO GMBH Registration: 8010908 View Registration
ANTHOGYR Registration: 8020776 View Registration
FFDM TIVOLY Registration: 8023007 View Registration
VERTEX-DENTAL B.V. Registration: 8030452 View Registration
DENTATUS AB Registration: 8030870 View Registration
MAILLEFER INSTRUMENTS HOLDING SARL Registration: 8031010 View Registration
CENDRES+METAUX SA Registration: 8031058 View Registration
Falcon Surgical Co. (Pvt.) Ltd. Registration: 8040278 View Registration
ACCOMPANY SURGICAL Registration: 8041151 View Registration
STORZ AM MARK GMBH Registration: 8043554 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
FORESTADENT BERNHARD FORSTER GMBH Registration: 8044058 View Registration
WESLEY COE (CAMBRIDGE) LTD Registration: 8044131 View Registration
KLS Martin SE & Co. KG Registration: 9610905 View Registration
HEBUMEDICAL GMBH Registration: 9611112 View Registration
NAKANISHI INC. Registration: 9611253 View Registration
HELMUT ZEPF MEDIZINTECHNIK GMBH Registration: 9611367 View Registration
DENTECH CORP. Registration: 9611450 View Registration
Dentaurum GmbH & Co. KG Registration: 9611458 View Registration
NOBEL BIOCARE AB Registration: 9611992 View Registration
NOBEL BIOCARE AB, PRODUKTION Registration: 9611993 View Registration
IVOCLAR VIVADENT AG Registration: 9612352 View Registration
Dentsply IH AB Registration: 9612468 View Registration
HI TEC IMPLANTS, LTD. Registration: 9613283 View Registration
INSTITUT STRAUMANN AG Registration: 9613348 View Registration
ALTATEC GMBH Registration: 9613866 View Registration
TRACK OF SURGICAL Registration: 9614068 View Registration
Straumann Villeret SA Registration: 9614404 View Registration
SIRONA DENTAL SYSTEMS GMBH Registration: 9614977 View Registration
OSUNG MND CO., LTD. Registration: 9616119 View Registration
SOADCO, S.L. Registration: 9617542 View Registration
STECO-SYSTEM-TECHNIK GMBH & CO. KG Registration: 9617660 View Registration
DEN TAG S.R.L. Registration: 9680026 View Registration
MEDESY srl Registration: 9680244 View Registration
JOSEF GANTER FEINMECHANIK GMBH Registration: 9680605 View Registration
SDS de Mexico S. de R.L. de C.V. Registration: 9680845 View Registration
RHEIN 83 SRL Registration: 9680939 View Registration
DETAX GMBH Registration: 9680954 View Registration
DEGUDENT GMBH Registration: 9681199 View Registration
W&H DENTALWERK BUERMOOS GMBH Registration: 9681479 View Registration
Sirona Dental Systems GmbH Registration: 9681851 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0014-2022

Recall Parameters & Description

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