International safety notice

Technical name: Bone graft and associated devices

Brazil / Anvisa · BRA · Nov 22, 2016

Key facts

Title Technical name: Bone graft and associated devices
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Phosphocalcium ceramic for bone filling TCH // Technical name: Bone graft and associated devices // ANVISA registration number: 80240590003 // Risk class: IV - Maximum Risk // Affected models: K40405G - K40415G - K40420B // Affected lots: Model: K40405G - Lot: 404/13285;
Manufacturer EMPRESA DETENTORA DO REGISTRO ORTECH MEDICAL COM IMP EXP LTDA RUA JORGE AUGUSTO 83 SALAS 55 A 58 SÃO PAULOSP ORTECHTERRACOMBR 11 25323710 FABRICANTE KASIOS 18 CHEMIN DE LA VIOLETTE 31240 L UNION FRANCE
Models 13285, 12229, 80240590003, K40405G, K40420B, K40415G, 12059
Date Nov 22, 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

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