International safety notice
Alert 2650 (Technosurveillance) - Stryker do Brasil - CONSOLE 110V (5450850000), CONSOLE 230V (5450852000) Lack of important information in the product's instructions for use.
Brazil / Anvisa · BRA · Aug 22, 2018
Key facts
| Title | Alert 2650 (Technosurveillance) - Stryker do Brasil - CONSOLE 110V (5450850000), CONSOLE 230V (5450852000) Lack of important information in the product's instructions for use. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | - Nome Comercial: CONSOLE 110V (5450850000), CONSOLE 230V (5450852000) - Technical Name: SONOPET ULTRASONIC SURGICAL SYSTEM - ANVISA registration number: 80005430352 - Risk Class: III - Affected model: CONSOLE 230V SONOPET and CONSOLE 110V C PEDAL AND POST SONOPET - Affected serial numbers: See attached Letter to the Customer in the Alert published on the Anvisa website |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO STRYKER DO BRASIL RUA URUSSUÍ 300 7º ANDAR SÃO PAULO SP TEL 11 51892503 EMAIL QUALIDADESTRYKERCOM FABRICANTE DO PRODUTO STRYKER MEDTECH JAPÃO |
| Models | 5450852000, 80005430352, 5450850000 |
| Date | Aug 22, 2018 |
| 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