International safety notice
Alert 2742 (Technosurveillance) - Biomet 3I - Set of instruments for implant - Review / removal of Zimmer Hip Prosthesis - Possibility of creases in the packaging sealing area.
Brazil / Anvisa · BRA · Nov 30, 2018
Key facts
| Title | Alert 2742 (Technosurveillance) - Biomet 3I - Set of instruments for implant - Review / removal of Zimmer Hip Prosthesis - Possibility of creases in the packaging sealing area. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Set of instruments for implantation - Revision and removal of Zimmer Hip Prosthesis; Technical Name: Instrumental kit ANVISA registration number: 80044680281; Risk Class: I Affected model: See attachment "List of lots at risk" Affected serial numbers: See attachment "List of lots at risk" |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOMET 3I DO BRASIL COMÉRCIO DE APARELHOS MÉDICOS LTDA CNPJ 02913684000148 RUA MACHADO BITTENCOURT Nº 361 12º ANDAR SÃO PAULO SP TEL 11 35681339 EMAIL ANAHAASZIMMERBIOMETCOM FABRICANTE DO PRODUTO ZIMMER INC 1800 WEST CENTER STREET WARSAW IN ESTADOS UNIDOS DA AMÉRICA |
| Models | 80044680331, 80044680281 |
| Date | Nov 30, 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