FDA Import Refusal BJY-0710313-6/4/5 — BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA

BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA — FEI 3009685086

The FDA refused shipment BJY-0710313-6/4/5 from BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS LTDA (Brazil) on Sep 17, 2012. The refused product falls under Devices — PROSTHESIS, SHOULDER, HUMERAL (BIPOLAR HEMI-SHOULDER) METAL/POLYMER, CEMENTED OR UNCEMENTED. Cited charges: 118,341,508 This firm has 5 or more other import refusals on record.

Refusal details

Date
Sep 17, 2012
Country
Brazil
Product Category
Devices
Product Code
87MJT PROSTHESIS, SHOULDER, HUMERAL (BIPOLAR HEMI-SHOULDER) METAL/POLYMER, CEMENTED OR UNCEMENTED
Charges
118,341,508

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.