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FDA Import Refusal 799-5995463-4/11/2 — MatOrtho Ltd

MatOrtho Ltd — FEI 3008985661

The FDA refused shipment 799-5995463-4/11/2 from MatOrtho Ltd (United Kingdom) on June 1, 2018. The refused product falls under Devices — PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. Cited charges: 118,508 This firm has 2 other import refusals on record.

Refusal Details

Date
June 1, 2018
Country
United Kingdom
Product Category
Devices
Product Code
87JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Charges
118,508

Recent inspections

  • 1191982 (NAI Thu Nov 03 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120806 (VAI Thu Mar 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949343 (VAI Thu Oct 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-5995463-4/11/1 (Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-5690988-8/11/1 (Wed May 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources