International safety notice
Alert 2665 (Technosurveillance) - Bioteck Industry and Commerce, Importation and Exportation of Bio-Absorbable Implants Ltda.
Brazil / Anvisa · BRA · Sep 4, 2018
Key facts
| Title | Alert 2665 (Technosurveillance) - Bioteck Industry and Commerce, Importation and Exportation of Bio-Absorbable Implants Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Goldteck Anchor 5.3 x 17mm Technical Name: Non-absorbable orthopedic suture anchor ANVISA registration number: 80371250017 Risk Class: III Affected model: PGOLPK005 Affected serial numbers: 01 (one) batch: PGOL819 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOTECK INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE IMPLANTES BIOABSORVÍVEIS LTDA CNPJ 06232491000182 RUA MARIA AUGUSTA GENEROSO ESTRELA 1060 BAIRRO RUBEM BERTA PORTO ALEGRE RS TEL 51 32722015 EMAIL VANIABIOTECKIMPLANTSCOM FABRICANTE DO PRODUTO BIOTECK INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE IMPLANTES BIOABSORVÍVEIS LTDA RUA MARIA AUGUSTA GENEROSO ESTRELA 1060 BAIRRO RUBEM BERTA PORTO ALEGRERS BRASIL |
| Models | 80371250017, PGOLPK005, PGOL819 |
| Date | Sep 4, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1