International safety notice

Technical Names: 1.Biopsy instrument 2.Spacer; 3.Spacer; 4. Rigid fixation system for special plates for osteosynthesis; 5.Bone cement; 6.Bone cement; 7.Bone cement; 8.Drainage system; 9.Orthopedic cement applicator and mixer; 10.Orthopedic cement mixer; 11.Orthopedic cement mixer; 12.Orthopedic cement mixer.

Brazil / Anvisa · BRA · Dec 4, 2012

Key facts

Title Technical Names: 1.Biopsy instrument 2.Spacer; 3.Spacer; 4. Rigid fixation system for special plates for osteosynthesis; 5.Bone cement; 6.Bone cement; 7.Bone cement; 8.Drainage system; 9.Orthopedic cement applicator and mixer; 10.Orthopedic cement mixer; 11.Orthopedic cement mixer; 12.Orthopedic cement mixer.
Regulator Brazil / Anvisa
Country BRA
Brand 1.SUBTON VTP VERTEBRAL BODY PUNCTURE CANNULA FOR VERTEBROPLASTY AND BIOPSY - REG. 2.SUBITON HIP SPACER - NO REGISTRATION; 3.SUBITON KNEE SPACER - NO REGISTRATION; 4.MAXILLOFACIAL - NO REGISTRATION; 5.RADIO-OPAQUE BONE CEMENT FOR MANUAL APPLICATION - WITHOUT REGISTRATION; 6. STERILE RADIO-OPAQUE LOW VISCOSITY BONE CEMENT FOR APPLICATION WITH A SYRINGE - WITHOUT REGISTRATION; 7.RADIO-OPAQUE BONE CEMENT FOR MANUAL APPLICATION - WITHOUT REGISTRATION; 8.SUBITON HEMOSCTOR - REG. 9.SUBITON GUN SYRINGE - REG. 10.SUBIMIX VTP - REGISTRATION SUSPENDED 80038749002; 11.SUBITON BOWL - REGISTRATION SUSPENDED 80038749003; 12.SUBIMIX V - REGISTRATION SUSPENDED 80038749005.
Manufacturer ANGIOLINE LTDA CNPJ 02305681000121 ENDEREÇO RUA PAISSANDU Nº 281 PAISSANDU RECIFEPE
Models 80038749002, 80038749001, 6.CIMENTO, 80038749005, 10.SUBIMIX, 5.CIMENTO, 7.CIMENTO, 11.SUBITON, 4.MAXILOFACIAL, 80038749003, 9.SERINGA, 8.SUBITON and 6 more
Date Dec 4, 2012
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 10–99 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

Browse all International device safety notices