Safety Alert for Knee Arthroplasty System / Knee Prosthesis; models: 6307-00-006 / 6307-00-008 / 6307-00-009; registration 80199020013; risk class III; lots: 61988031; 62054615; 62041152; 6,180,029; 61806575; 62005748; 61815746; 62041157; 61822616; 62005756; 62054626; 62068198; 62128274; 61831823; 61831831; 61850057; 61824682.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDSINTESE Importação, exportação e comércio Eireli.; Zimmer Inc..

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
    1812
  • Date
    2016-02-01
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    The company made a potential risk assessment and concluded that packaging adhesion is unlikely to cause an adverse effect on the patient or even the implant. As reported by the company, if wear particles generated from the film / adhesion residue of LDPE packaging were expected to elicit similar biological reactions from those of ultra high molecular weight polyethylene and are unlikely to increase the possibility of peri-prosthetic osteolysis .
  • Reason
    Some components of highly polished implants were packed in a low density polyethylene (ldpe) casing with the potential to adhere to the implants.
  • Action
    Pick up and return to the manufacturer. Action code FAM-03. The distributors must carry out the traceability of the products in their inventory. When you find products related to lots of this field action, it segregates them. The company will collect the affected units.