Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2014 - (Recall #: Z-0849-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker 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

Product Classification:

Class II

Date Initiated: November 7, 2013

Date Posted: February 5, 2014

Recall Number: Z-0849-2014

Event ID: 67055

Reason for Recall:

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.

Status: Terminated

Product Quantity: 34 units

Code Information:

Catalog Number 1806-0073S Lot Code K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3

Distribution Pattern:

US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA.

Voluntary or Mandated:

Voluntary: Firm initiated