International safety notice
Alert 2509 (Technovigilance) - Wright Medical Brasil Ltda Me - Darco Locking Screws Possibility of screws passing through the plate during a surgical procedure.
Brazil / Anvisa · BRA · Mar 12, 2018
Key facts
| Title | Alert 2509 (Technovigilance) - Wright Medical Brasil Ltda Me - Darco Locking Screws Possibility of screws passing through the plate during a surgical procedure. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Darco Locking Screws Technical name: Non-bioabsorbable, non-sterile orthopedic bone screw ANVISA registration number: 80491360021 Risk class: III Affected model: DC2820014; Affected serial number: 1585745; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO WRIGHT MEDICAL BRASIL LTDA ME CNPJ 08051626000139 RUA JOAQUIM FLORIANO N 466 ANDAR 15 E 21 CONJ 1505 2111 E 2112 ITAIM BIBI CEP 04534002 SÃO PAULO SP FABRICANTE WRIGHT MEDICAL TECHNOLOGY INC 1023 CHERRY ROAD MEMPHIS TN 38117 ESTADOS UNIDOS TELEFONE 9014516356 9012299589 EMAIL MATTHEWPARRISHWRIGHTCOM |
| Models | DC2820028, 1583922, 1588312, DCS2820020, 1583369, 1582608, 1588840, 1588216, 1584939, DC2820030, 1583924, 1585615 and 76 more |
| Date | Mar 12, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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