Home / Import refusals / 799-8253574-0/11/20

FDA Import Refusal 799-8253574-0/11/20 — Howmedica Osteonics Corp.

Howmedica Osteonics Corp. — FEI 3003070421

The FDA refused shipment 799-8253574-0/11/20 from Howmedica Osteonics Corp. (United States) on September 3, 2020. The refused product falls under Devices — PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/. Cited charges: 3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 3, 2020
Country
United States
Product Category
Devices
Product Code
87MBH PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/
Charges
3280,341

Recent inspections

  • 1223869 (VAI Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1147430 (NAI Tue Jun 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918064 (VAI Mon Mar 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 830554 (VAI Tue Apr 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 644241 (NAI Fri Jan 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-8253574-0/11/5 (Thu Sep 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8253574-0/11/11 (Thu Sep 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8253574-0/11/13 (Thu Sep 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8253574-0/42/2 (Thu Sep 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8253574-0/11/2 (Thu Sep 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources