Events

Alerte De Sécurité sur VARIOUS PRODUCTS /// 1.Commercial Name: Knee Prosthesis - Registration: 10108770064 - Risk Class: III - Models and Lots in ANNEX; /// 2.Commercial Name: Spongy Screw - Registration: 10108770074 - Risk Class: III - Models and Lots in ANNEX; /// 3. Trade Name: Shoulder Prosthesis - Registration: 10108770083 - Risk Class: III - Models and Lots in ANNEX; /// 4. Trade Name: NON-CONVENTIONAL ENDOPROTES FOR TIBIA, FEMUR OR UMERO - Registration: 10108770086 - 5. PRODUCT NAME: FEMALE COMPONENT IMPOL - Registration: 10108770089 - Risk Class: III - Models and Lots in ANNEX; /// 6. Trade Name: FEMALE COMPONENT IMPOL - Registration: 10108770089 - Risk Class: III - Models and Lots in ANNEX; /// 7. Trade Name: SLIDING SCREW - Registration: 10108770090 - Risk Class: III - Models and Lots in ANNEX; Name of Product: Tibial Metallic Base - Registration: 10108770091 - Risk Class: III - Models and Lots in ANNEX; /// 9. Trade Name: CORTICAL SCREW - Registration: 10108770092 - Risk Class: III - Models and Lots in ANNEX; /// 10. Trade Name: PLACA TUBO LARGE FRAGMENTS - Registration: 10108770094 - Risk Class: III - Models and Lots in ANNEX; /// 11. Trade Name: RETAIL PLATE - Registration: 10108770095 - Risk Class: III - Models and Lots in ANNEX; /// 12. Trade Name: MODULAR FEMALE HEAD IN STEEL - Registration: 10108770096 - Hazard Class: III - Model and Lots in ANNEX; /// 13. Trade Name: PROTEIN OF ELBOW FOR ARTHROPLASTY UMERO-ULNAR TOTAL CEMENTED - Registration: 10108770097 - Risk Class: III - Models and Lots in ANNEX; /// 14. Trade Name: Intramedine haste BLOCKED - Registration: 10108770099 - Risk Class: III - Models and Lots in ANNEX; /// 15. Trade Name: MODIFIED CEMENT FEMALE STEM - Registration: 10108770106 - Risk Class: III - Models and Lots in ANNEX; // 16. Trade Name: ACETABULAR COMPONENT IN CEMENTED POLYETHYLENE - Registration: 10108770107 - Risk Class: III - Models and Lots in ANNEX; /// 17. Trade Name: System for total knee prosthesis - Registration: 10108770108 - Class of Risk: III - Models and Lots in ANNEX; /// 18. Trade Name: SYSTEM FOR PARTIAL ARTHROPLASTY V GENERATION - Registration: 10108770109 - Hazard Class: III - Models and Lots in ANNEX; /// 19. Trade Name: POLYMERIC ACETABULAR NUCLEUS WITH METALLIC JOINT SURFACE - Registration: 10108770111 - Hazard Class: III - Models and Lots in ANNEX ; /// 20. Trade Name: PINO DE SCHANZ - Registration: 10108770114 - Risk Class: III - Models and Lots in ANNEX; /// 21. Trade Name: Head for Integral Shoulder Arthroplasty - Registration: 10108770115 - Class of /// 22. Trade Name: FIXATION SYSTEM FOR THE LARGE AND SMALL SPACES OF STAINLESS STEEL FRAGMENTS - IMPOL - Registration: 10108770117 - Risk Class: III - Models and Lots in ANNEX ; /// 23. Trade Name: ENDOPROTESES INFERIOR MEMBERS EUROTOP - Registration: 10108770118 - Risk Class: III - Models and Lots in ANNEX; /// 24. Trade Name: Modular System for Shoulder Arthroplasty Eccentra II - Registry: 10108770122 - Risk Class: III - Models and Lots in ANNEX; / 25. Trade Name: INSERTO TIBIAL - IMPOL - Registration: 10108770123 - Class of Risk: III - Models and Lots in ANNEX; /// 26. Trade Name: INSERTO TIBIAL - IMPOL - Models and Lots in ANNEX; /// 27. Trade Name: Large and Small Blocked Regional Special Panels System - Impol - Registration: 10108770125 - Risk Class: III - Models and Lots in ANNEX; ///

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par IMPOL INSTRUMENTAL E IMPLANTES LTDA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1747
  • Date
    2015-11-19
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    The Company is sending a Letter to the Physicians orienting regarding the follow-up of patients with implanted products. (ATTACHMENT)
  • Cause
    During investigation inspection the manufacture and commercialization of implant products with the material without specification for implants and in disagreement with the anvisa registers 10108770092 and 10108770117 were verified; as well as the manufacture of health products without the fulfillment of good manufacturing practices requirements, according to resolution rdc 16/2013.
  • Action
    ANVISA has determined, as a measure of sanitary interest, throughout Brazil the suspension of the manufacture, distribution, sale, use or implantation of ALL PRODUCTS manufactured by Impol Instrumental and Implantes Ltda. (CNPJ: 49337413 / 0001-55), as well as the collection of all products on the market. (Resolution RE No. 2,892, dated 10/15/2015, published in DOU No. 198, Section 1, page 25, dated 10/16/2015 - in EXHIBIT).

Device

VARIOUS PRODUCTS /// 1.Commercial Name: Knee Prosthesis - Registration: 10108770064 - Risk Class:...

Manufacturer

IMPOL INSTRUMENTAL E IMPLANTES LTDA