International safety notice
Technical name: Disc replacement interbody spacing device
Brazil / Anvisa · BRA · May 31, 2017
Key facts
| Title | Technical name: Disc replacement interbody spacing device |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Shadowteck Cervical Intervertebral Spacer Technical name: Disc replacement interbody spacing device ANVISA registration number: 80371250016 Risk class: III Affected model: PSHCPB003 - Shadowteck Cervical Intervertebral Spacer 6.0 mm Affected serial numbers: 01 (one) batch named PSHC746. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOTECK INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE IMPLANTES BIOABSORVÍVEIS LTDA RUA MARIA AUGUSTA GENEROSO ESTRELA 1060 BAIRRO RUBEM BERTA PORTO ALEGRERS 51 32722015 FABRICANTE BIOTECK INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE IMPLANTES BIOABSORVÍVEIS LTDA RUA MARIA AUGUSTA GENEROSO ESTRELA 1060 BAIRRO RUBEM BERTA PORTO ALEGRERS 51 32722015 |
| Models | 80371250016, PSHC746, PSHCPB003 |
| Date | May 31, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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