International safety notice
Alert 2737 (Technovigilance) - Amplitude Latin America S.A. - Instrumental Knee - Common Base (SCORE® Revision), Femoral impactor with offset connector - Possibility of incorrect lateral recording.
Brazil / Anvisa · BRA · Nov 26, 2018
Key facts
| Title | Alert 2737 (Technovigilance) - Amplitude Latin America S.A. - Instrumental Knee - Common Base (SCORE® Revision), Femoral impactor with offset connector - Possibility of incorrect lateral recording. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Instrumental Knee - Common Base (SCORE® Review) Technical Name: Instrumental Kit ANVISA registration number: 80726260021 Risk Class: I Affected Model: Single Items 2-021360D and 2-021360G (Offset Connector Femoral Impactors) Affected serial numbers: 1500149 / 1500153 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO AMPLITUDE LATIN AMERICA SA CNPJ 10978692000109 AVENIDA 80A 599 RIO CLARO SP TEL 19 35222380 EMAIL RTAMPLITUDELATAMCOM FABRICANTE DO PRODUTO AMPLITUDE SAS ZONE D ACTIVITÉ MOZART 2 11 COURS OFFENBACH FRANÇA |
| Models | 1500149, 2-021360D, 2-021360G, 80726260021, 1500153 |
| Date | Nov 26, 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