Valor Ankle Fusion Nail System

• 2 recalls, same reason

  • Terminated Z-1375-2018 FDA Class II ·initiated 14 Mar 2018
  • Terminated Z-1376-2018 FDA Class II ·initiated 14 Mar 2018

  Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.

• • Terminated Z-0566-2020 FDA Class II ·initiated 8 Nov 2016

  The firm discovered a lack of adequate documentation confirming sterility on certain products.

• 2 recalls, same reason

  • Terminated Z-1484-2012 FDA Not yet classified ·initiated 5 Apr 2012
  • Terminated Z-1485-2012 FDA Not yet classified ·initiated 5 Apr 2012

  The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.

510(k) Number

K090857 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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