International safety notice
Alert 2854 (Technovigilance) KaVo do Brasil Indústria e Comércio Ltda Nobel Biocare Stainless Steel Sterile Instruments Possibility of compromising sterility due to failure in the blister sealing process.
Brazil / Anvisa · BRA · Apr 22, 2019
Key facts
| Title | Alert 2854 (Technovigilance) KaVo do Brasil Indústria e Comércio Ltda Nobel Biocare Stainless Steel Sterile Instruments Possibility of compromising sterility due to failure in the blister sealing process. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Nobel Biocare Sterile Stainless Steel Instruments Technical Name: Instruments for Dental Use ANVISA registration number: 10064010192 Risk Class: I Affected model: 37471 - Implant Removal Instrument Ext Hexagonal Connection and Triple Channel NP/RP 22mm Affected serial numbers: Lot 73315 Have been sold and are being recalled in the field. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO KAVO DO BRASIL INDÚSTRIA E COMÉRCIO LTDA CNPJ 84683556000110 RUA CHAPECÓ 86 SAGUAÇU CEP 89221040 JOINVILLE SC TEL 55 47 34510231 EMAIL LUIDGIPEDRAZZAKAVOKERRCOM FABRICANTE DO PRODUTO NOBEL BIOCARE AB PO BOX 5190 SE402 26 VÄSTRA HAMNGATAN 1 GÖTEBORG 411 17 SWEDEN SUÉCIA |
| Models | 73600, 10064010192, 73315, 73491, 37471 |
| Date | Apr 22, 2019 |
| 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