T2 Tibial Nailing System

• 2 recalls, same reason

  • Ongoing Z-2171-2021 FDA Class II ·initiated 27 May 2021
  • Ongoing Z-2170-2021 FDA Class II ·initiated 27 May 2021

  The devices have a different inner diameter than the diameter specified on the outer box label.

• • Terminated Z-0882-2016 FDA Class II ·initiated 21 Jan 2016

  During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

• • Terminated Z-0065-2015 FDA Class II ·initiated 24 Jul 2014

  Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.

510(k) Number

K131365 ↗

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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See all devices from Stryker Trauma AG →