International safety notice

Alert 2536 (Technosurveillance) Orthosynthesis - Modular Femoral Head Recall of product outside of specifications.

Brazil / Anvisa · BRA · Apr 6, 2018

Key facts

Title Alert 2536 (Technosurveillance) Orthosynthesis - Modular Femoral Head Recall of product outside of specifications.
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Modular Femoral Head Technical name: Hip prosthesis ANVISA registration number: 10223710079 Risk class: III Affected model: Cone Interchangeable Head 12/14 22 S Affected Lot/Series Numbers: 1660G17;
Manufacturer EMPRESA DETENTORA DO REGISTRO ORTOSINTESE INDÚSTRIA E COMÉRCIO LTDA RUA PROFESSOR AFFONSO JOSÉ FIORAVANTI 63 SP SÃO PAULO TEL 11 39484000 NAKAMURAORTOSINTESECOMBR FABRICANTE ORTOSINTESE INDÚSTRIA E COMÉRCIO LTDA RUA PROFESSOR AFFONSO JOSÉ FIORAVANTI 63 SP SÃO PAULO
Models 1579L17, 1630G17, 3554H17, 1660G17, 1662G17, 3553H17, 3548H17, 10223710079
Date Apr 6, 2018
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice

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