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FDA Import Refusal 231-6913840-6/11/4 — Stanmore Implants Worldwide Ltd.

Stanmore Implants Worldwide Ltd. — FEI 3004105610

The FDA refused shipment 231-6913840-6/11/4 from Stanmore Implants Worldwide Ltd. (United Kingdom) on May 4, 2018. The refused product falls under Devices — PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER. Cited charge: 2780 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 4, 2018
Country
United Kingdom
Product Category
Devices
Product Code
87KRO PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Charges
2780

Recent inspections

  • 1198598 (NAI Thu Feb 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 894278 (OAI Thu Jul 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • BYA-1804573-2/11/1 (Wed Jun 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-6913840-6/11/1 (Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-6913840-6/11/2 (Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-6913840-6/11/3 (Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-6913840-6/11/5 (Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources