International safety notice
Alert 2766 (Technosurveillance) - Johnson & Johnson - Proximate Circular Hemorrhoidal Stapler - Possibility of partial and irregular stapling due to assembly failure in specific batches.
Brazil / Anvisa · BRA · Jan 11, 2019
Key facts
| Title | Alert 2766 (Technosurveillance) - Johnson & Johnson - Proximate Circular Hemorrhoidal Stapler - Possibility of partial and irregular stapling due to assembly failure in specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Proximate Circular Hemorrhoidal Stapler Technical Name: Surgical Stapler ANVISA registration number: 80145901097 Risk Class: III Affected model: PPH Affected serial numbers: Code: PPH01 PROXIMATE® Circular Hemorrhoidal Stapler for HCS. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO JOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 AV JUSCELINO KUBITSCHEK Nº 2041 ANDARES 8º E 9º COMPLEXO JK BLOCO B SÃO PAULO SP TEL 55 11 27882245 EMAIL VOLIVEI2ITSJNJCOM FABRICANTE DO PRODUTO ETHICON ENDOSURGERY LLC PR9931 SAN LORENZO 00754 PORTO RICO ESTADOS UNIDOS |
| Models | P94A20, P9461W, P93Y58, P94765, PPH01, P94D3N, P94F3Z, P94117, P9420Z, P9441H, P93L1M, P9450L and 20 more |
| Date | Jan 11, 2019 |
| 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