Events

Safety Alert for POLYBONE ORIGINAL (registration 10355870054) Technical name: BONES AND ASSOCIATED DEVICES / ORTHOPEDIC CEMENT, WITHOUT MEDICINE ANVISA registration number: 10355870030 Hazard class: IV Affected model: PBBG205 (registration 10355870030) ) / PBO-5 and PBO-10 (registration 10355870054) Affected serial numbers: PBBG205 - Batch: P2110081; PBBG205 - Batch: P2110097; PBBG205 - Batch: P2120036; PBBG205 - Batch: P2120038; PBBG205 - Lot: P2140011; PBBG205 - Batch: P2140036; PBBG205 - Batch: P2150024; PBBG205 - Batch: P2150029; PBBG205 - Batch: P2150031; PBBG205 - Lot: P2150033; PBBG205 - Lot: P2160005; PBBG205 - Lot: P2160015; PBO-5 - Lot: P02110047; PBO-5 - Lot: P2150005; PBO-10 - Lot: P2110096; PBO-10 - Lot: P2130049; PBO-10 - Lot: P2140040; PBO-10 - Lot: P2150001; PBO-10 - Lot: P2150010; PBO-10 - Lot: P2150018; PBO-10 - Lot: P2150020; PBO-10 - Lot: P2150028; PBO-10 - Lot: P2150030; PBO-10 - Lot: P2150032.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomédica Equipamentos e Suprimentos Hospitalares Ltda.; Kyungwon Medical Co., Ltd..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2266
  • Date
    2017-04-12
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    It is recommended to stop immediately the use of the affected products and their segregation, with subsequent return to the importer; the importer will be responsible for returning the affected products to the manufacturer. It is also recommended that any adverse events noted should be reported to the importer and to the competent health authority.
  • Reason
    Resolution re no. 918 of april 4, 2017 was published in the official gazette of the federal government of 04/10/2017 (no. 69, section 1, page 47), in which the national health surveillance agency ) determines the suspension of the importation, distribution, marketing and use of polybone original and polybone products, considering the completion of the international inspection report unsatisfactory for kyungwon medical co., ltd and that most of the nonconformities found in the report are directly related with the products manufactured.
  • Action
    Field Action Code 4 triggered under the responsibility of the company BIOMÉDICA EQUIPAMENTOS E SUPRIMENTOS HOSPITALARES LTDA. Company will make collection for later return to the manufacturer.

Device

POLYBONE ORIGINAL (registration 10355870054) Technical name: BONES AND ASSOCIATED DEVICES / ORTHO...

Manufacturer

Biomédica Equipamentos e Suprimentos Hospitalares Ltda.; Kyungwon Medical Co., Ltd.
  • Source
    ANVSANVISA