International safety notice
Technical name: Modular system for total arthroplasty
Brazil / Anvisa · BRA · Aug 1, 2016
Key facts
| Title | Technical name: Modular system for total arthroplasty |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Product name: Hip Arthroplasty System - Hybrid // Risk class: III (High Risk)// Technical name: Modular system for total arthroplasty // Registration No.: 10417940085// Affected model(s): PHENOM Poly Acetabular Insert (04.13.13.xxxxx) / PHENOM Poly Acetabular Insert Posterior Roof (04.13.14.xxxxx)Lot(s): Various// Products manufactured before 08/25/2016 Check the affected Codes/Batches |
| Manufacturer | EMPRESA FABRICANTE DETENTORA DO REGISTRO MDT INDÚSTRIA COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE IMPLANTES CNPJ 01025974000192 ENDEREÇO AVENIDA BRASIL 2983 DISTRITO INDUSTRIAL RIO CLAROSP BRASIL CONTATO SAC 19 21116500 OU FABRICIOBELINIVINCULACOMBR |
| Models | 04.13.14.xxxxx, 04.13.13.xxxxx, 10417940085 |
| Date | Aug 1, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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