Mets Smiles Total Knee Replacement

• 5 recalls, same reason

  • Terminated Z-0820-2017 FDA Class II ·initiated 7 Dec 2016
  • Terminated Z-0822-2017 FDA Class II ·initiated 7 Dec 2016
  • Terminated Z-0823-2017 FDA Class II ·initiated 7 Dec 2016
  • Terminated Z-0824-2017 FDA Class II ·initiated 7 Dec 2016
  • Terminated Z-0821-2017 FDA Class II ·initiated 7 Dec 2016

  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.

• • Terminated Z-2553-2016 FDA Class II ·initiated 31 May 2016

  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.

510(k) Number

K120992 ↗

FDA Product Code

KRO

FDA applicant

Stanmore Implants Worldwide , Ltd.

Device Class

Class II

Regulation

21 CFR Part 888.3510

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Jts Extendeable Implant

  Class II

  FDA 510(k) K092138 Active Cleared 22 Mar 2011

• Jts Extendible Distal Femoral Implant

  Class II

  FDA 510(k) K133152 Active Cleared 22 Jan 2014

• Patient Specific Distal Femoral Open recall

  Class II

  FDA 510(k) K140898 Active Cleared 20 Jan 2015

• Mets Modular Total Femur

  Class II

  FDA 510(k) K121055 Active Cleared 19 Sep 2012

• Mets Modular Proximal Femur

  Class II

  FDA 510(k) K121056 Active Cleared 20 Sep 2012

• Sculptor Robotic Guidance Arm (RGA)

  Class II

  FDA 510(k) K121765 Active Cleared 11 Jan 2013

See all devices from Stanmore Implants Worldwide Ltd →