International safety notice
Technical name: GRAFT FOR BONES AND ASSOCIATED DEVICES / ORTHOPEDIC CEMENT, MEDICINE-FREE
Brazil / Anvisa · BRA · Apr 12, 2017
Key facts
| Title | Technical name: GRAFT FOR BONES AND ASSOCIATED DEVICES / ORTHOPEDIC CEMENT, MEDICINE-FREE |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: POLYBONE BONE GRAFT (registration 10355870030) / POLYBONE ORIGINAL (registration 10355870054) Technical name: GRAFT FOR BONES AND ASSOCIATED DEVICES / ORTHOPEDIC CEMENT, WITHOUT MEDICATION ANVISA registration number: 10355870030 Risk class: IV Affected model: PB BG205 (registration 10355870030 ) / PBO-5 and PBO-10 (registration 10355870054) Affected serial numbers: PBBG205 - Lot: P2110081; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOMÉDICA EQUIPAMENTOS E SUPRIMENTOS HOSPITALARES LTDA CNPJ 01299509000140 ENDEREÇO SIA TRECHO 03 LOTES 625695 BLOCO C SALAS 228 230 E 232 ZONA INDUSTRIAL GUARÁ BRASÍLIA DF TEL 61 33634422 FABRICANTE KYUNGWON MEDICAL CO LTD ENDEREÇO 765 JEONGJUNGYEONJERO OSONGEUP HEUNGDEOKGU CHEONGJUSI CHUNGCHEONGBUKDO CORÉIA DO SUL TEL 82 2 2038 8089 |
| Models | P2160015, P2150030, P2150010, P2150032, P2140040, P02110047, PBO-5, 10355870054, 10355870030, P2110097, P2140036, P2140011 and 17 more |
| Date | Apr 12, 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