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FDA Import Refusal BDU-0015500-8/1/2 — Advanced Surgical Design & Manufacture, Ltd.

Advanced Surgical Design & Manufacture, Ltd. — FEI 3003124946

The FDA refused shipment BDU-0015500-8/1/2 from Advanced Surgical Design & Manufacture, Ltd. (Australia) on May 31, 2011. The refused product falls under Devices — PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. Cited charges: 2780,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 31, 2011
Country
Australia
Product Category
Devices
Product Code
87JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Charges
2780,341

Recent inspections

  • 749929 (OAI Thu Sep 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-0712169-7/1/1 (Fri Oct 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-7037634-0/1/1 (Mon Jun 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-0154003-1/1/1 (Wed Dec 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • BDU-0015500-8/1/1 (Tue May 31 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • BDU-0015500-8/1/3 (Tue May 31 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources