International safety notice
Alert 2773 (Technosurveillance) - Vincula - Pedicol Plus Posterior Spine System - Possibility, in specific batches, that one side of the Morse Cone Cross Link Hook has a thickness greater than that specified.
Brazil / Anvisa · BRA · Jan 16, 2019
Key facts
| Title | Alert 2773 (Technosurveillance) - Vincula - Pedicol Plus Posterior Spine System - Possibility, in specific batches, that one side of the Morse Cone Cross Link Hook has a thickness greater than that specified. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Pedicol Plus Posterior Spine System Technical Name: Posterior spine system for fixation to lamina, pedicle, apophysis or solid articular ANVISA registration number: 10417940083 Risk Class: III Affected model: affected codes: 04.09.29.55001, 04.09.29.55003 and 04.09.29.55004 Affected serial numbers: 04074S, 05402S, 05395S, 05398S, 05408S, 05412S, 06168S, 10534S, 07396T, 06349T, 06351T, 06901T. |
| 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 RODRIGOBOTELHOVINCULACOMBR FABRICANTE DO PRODUTO VINCULA INDUSTRIA COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE IMPLANTES SA AVENIDA BRASIL 2983 DISTRITO INDUSTRIAL BRASIL |
| Models | 06168S, 07396T, 06351T, 04.09.29.55004, 04074S, 05402S, 10534S, 06901T, 05408S, 04.09.29.55001, 10417940083, 04.09.29.55003 and 4 more |
| Date | Jan 16, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
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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.
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