Reported Feb 5, 2014 · Terminated

Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany…

Stryker Howmedica Osteonics Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2002

Is this the product you have?

  • Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen
  • Germany distributed in the USA byStryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip
  • Guide Wires for Smooth Tip Guide Wires
    • T2 Tibial Nailing Systems
    • T2 Femoral Nailing Systems
    • T2 Ankle Nailing Systems
    • and T2 Humerus Nailing Systems
Lot codes and dates
    • Catalog Number 1806-0073S Lot Code K06C3B4
    • K05ECF3
    • K05ECF2
    • K057298
    • K0432D3
Amount recalled
34 units

Where it was sold

Why it was recalled

Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, sterile.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 31, 2015 · Data as of Sep 19, 6:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.