International safety notice

Technical name: System for inverted total shoulder arthroplasty

Brazil / Anvisa · BRA · Jun 20, 2017

Key facts

Title Technical name: System for inverted total shoulder arthroplasty
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Comprehensive Reverse Shoulder System Technical name: System for reversed total shoulder arthroplasty ANVISA registration number: 80044680228 Risk class: IV Affected model: XL-115363;
Manufacturer EMPRESA DETENTORA DO REGISTRO BIOMET 3I DO BRASIL COMÉRCIO DE APARELHOS MÉDICOS LTDA CNPJ 02913684000148 ENDEREÇO RUA MACHADO BITTENCOURT 361 12º ANDAR SÃO PAULO SP 11 35681300 FABRICANTE BIOMET ORTHOPEDICS 56 EAST BELL DRIVE WARSAW IN ESTADOS UNIDOS
Models 80044680228, XL-115367, 630520, 488830, XL-115363
Date Jun 20, 2017
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

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