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FDA Import Refusal 275-1435124-9/3/8 — Aesculap AG

Aesculap AG — FEI 3002806315

The FDA refused shipment 275-1435124-9/3/8 from Aesculap AG (Germany) on March 16, 2011. The refused product falls under Devices — PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. Cited charge: 341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 16, 2011
Country
Germany
Product Category
Devices
Product Code
87JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Charges
341

Recent inspections

  • 1178394 (NAI Thu Jul 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987720 (NAI Thu Sep 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 939850 (NAI Thu Jul 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 841575 (NAI Thu Jul 04 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 809376 (NAI Tue Dec 04 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • SCS-6434004-0/60001/1 (Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • BON-1004700-9/11/1 (Mon May 05 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 275-1435124-9/3/1 (Wed Mar 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 275-1435124-9/3/16 (Wed Mar 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 275-1435124-9/3/4 (Wed Mar 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources