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Stanmore Implants Worldwide Ltd

Country not established

Devices
103
FDA recalls
8

What Stanmore Implants Worldwide Ltd makes

Stanmore Implants Worldwide Ltd manufactures modular orthopedic implants for the femur and knee, including extendable and patient-specific distal femoral implants, modular proximal and total femur systems, and a modular total knee replacement. Their portfolio also includes robotic guidance arms designed to assist in surgical planning and precision during joint replacement procedures.

These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States, where its products are authorised for use in orthopedic surgeries.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue103

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Company details

DUNS number
494989502

FDA recalls8

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 8 recalls initiated by Stanmore Implants Worldwide Ltd, the earliest on 2016-04-12 and the most recent on 2017-07-04. By recorded status: 8 terminated. The reasons filed fall into these groups: packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

7 initiated before 2017

  • 2017

    • 4 Jul 2017 Z-3104-2017 Class II Terminated Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. As a result, the prostheses in such cases failed to extend as intended. Distribution: US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX. Submission numbers: K092138, K133152, K140898

  • 2016

    • 7 Dec 2016 Z-0820-2017 Class II Terminated The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. Distribution: Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA Submission number: K120992
    • 7 Dec 2016 Z-0821-2017 Class II Terminated The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. Distribution: Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA Submission number: K120992
    • 7 Dec 2016 Z-0822-2017 Class II Terminated The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. Distribution: Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA Submission number: K120992
    • 7 Dec 2016 Z-0823-2017 Class II Terminated The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. Distribution: Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA Submission number: K120992
    • 7 Dec 2016 Z-0824-2017 Class II Terminated The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. Distribution: Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA Submission number: K120992
    • 31 May 2016 Z-2553-2016 Class II Terminated The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation. Distribution: Directly distributed to TX, further distributed to AL and MS Submission number: K120992
    • 12 Apr 2016 Z-1623-2016 Class II Terminated Incorrect component used to manufacture distal femoral replacement. Distribution: US distribution to OH.