FDA Import Refusal 112-0019250-3/1/1 — Orthoplastics Ltd

Orthoplastics Ltd — FEI 3000264985

The FDA refused shipment 112-0019250-3/1/1 from Orthoplastics Ltd (United Kingdom) on June 1, 2012. The refused product falls under Devices — PROSTHESIS, KNEE, JOINT, PATELLOFEMORALTIBIAL, SEMI-CONSTRAINED, CEMENTED, CERAMIC/POLYMER/METAL. Cited charges: 118,237,508

Refusal Details

Date
June 1, 2012
Country
United Kingdom
Product Category
Devices
Product Code
87NCN PROSTHESIS, KNEE, JOINT, PATELLOFEMORALTIBIAL, SEMI-CONSTRAINED, CEMENTED, CERAMIC/POLYMER/METAL
Charges
118,237,508