Class 2 Device Recall Stryker Howmedica Osteonics

• Date Initiated by Firm: November 07, 2013
• Date Posted: January 28, 2014
• Recall Status: Terminated on March 31, 2015
• Recall Number: Z-0849-2014
• Recall Event ID: 67055
• 510(K)Number: K042396
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: 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
• Code Information: Catalog Number 1806-0073S Lot Code K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Ms. Christie Samsa; 201-831-6365
• Manufacturer 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.
• FDA Determined Cause: Process design
• Action: The firm, Stryker, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 17, 2013 to its customers via e-mail. Preliminary notification letters and Product Accountability Forms were sent via FedEx on November 15, 2013 with return receipt to the Stryker locations. Notification and Product Accountability Forms were sent 12/18/2013 via Fed Ex with return receipt. Updated letters were sent via Fed Ex on 12/19/2013 with return receipt. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine affected devices in local inventory as well as retrieve any devices located in hospitals; inform users of the Medical Device Removal and pass this to all those individuals who need to be aware within your organization; return all affected products available to your location to: Stryker Osteosynthesis, c/o Colleen O'Meara, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ, 07430, REF: PFA#2013-168 or contact Stryker customer service and refer to PFA #2013-166 for returning the product to us; complete and return the enclosed Business Reply Form and fax a copy to: 1-865-251-3635 or email a copy to Recall Coordinator at aminah.crawford@stryker.com, and keep a copy of the completed and executed Business Reply form for your records. If you have any further questions, contact Manager, Regulatory Compliance at 1-201-972-2100 or email: colleen.omeara@stryker.com.
• Quantity in Commerce: 34 units
• Distribution: US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HSB