International safety notice
Alert 2740 (Technosurveillance) - Links - Cemented Femoral Stem, SPOAC NG Femoral Prosthesis - Possibility of damage to the packaging and compromising sterilization if the product is transported or stored in a vertical position.
Brazil / Anvisa · BRA · Nov 28, 2018
Key facts
| Title | Alert 2740 (Technosurveillance) - Links - Cemented Femoral Stem, SPOAC NG Femoral Prosthesis - Possibility of damage to the packaging and compromising sterilization if the product is transported or stored in a vertical position. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Cemented Femoral Stem Technical Name: Modular Stem for Hip Artorplasty ANVISA registration number: 10417940039 Risk Class: III Affected model: SPOAC NG Femoral Prosthesis: 04.30.02.37XXX, 09.30.02.37XXX, 04.30.05.44XXX, 09.30.05.44XXX, 04.30.50.XXXXX Affected serial numbers: See attachment "List of lots at risk" |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO VINCULA INDUSTRIA COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE IMPLANTES SA CNPJ 01025974000192 AVENIDA BRASIL 2983 DISTRITO INDUSTRIAL RIO CLARO SP TEL 19 21116500 EMAIL JMAXIMOVINCULACOMBR FABRICANTE DO PRODUTO VINCULA INDUSTRIA COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE IMPLANTES SA AVENIDA BRASIL 2983 DISTRITO INDUSTRIAL BRASIL |
| Models | 10417940039, 04.30.05.44XXX, 04.30.02.37XXX, 09.30.02.37XXX, 04.30.50.XXXXX, 09.30.05.44XXX |
| Date | Nov 28, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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