International safety notice

Alert 2549 (Technosurveillance) Biomet - Set of instruments for Zimmer trauma surgery Possibility of failures in the sterile barrier of the product (packaging).

Brazil / Anvisa · BRA · Apr 19, 2018

Key facts

Title Alert 2549 (Technosurveillance) Biomet - Set of instruments for Zimmer trauma surgery Possibility of failures in the sterile barrier of the product (packaging).
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Zimmer Trauma Surgery Instrument Set Technical name: Instrumental Kit ANVISA registration number: 80044680331 Risk class: I Affected model: 47-2255-008-01; Affected Lot/Series Numbers: 63696961;
Manufacturer EMPRESA DETENTORA DO REGISTRO BIOMET 3I DO BRASIL COMÉRCIO DE APARELHOS MÉDICOS LTDA CNPJ 02913684000148 RUA MACHADO BITTENCOURT 361 12º ANDAR SÃO PAULO SP TEL 11 35681339 EMAIL ANAHAASZIMMERBIOMETCOM FABRICANTE ZIMMER INC 1800 WEST CENTER STREET WARSAW IN ESTADOS UNIDOS DA AMÉRICA
Models 63705231, 47-2490-098-00, 63748390, 47-2490-098-01, 63721371, 63668698, 77006549, 63696961, 63748391, 47-2490-097-00, 47-2490-097-01, 80044680331 and 1 more
Date Apr 19, 2018
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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