Class 2 Device Recall Stryker Orthopaedics

• Date Initiated by Firm: September 21, 2015
• Date Posted: December 02, 2015
• Recall Status: Terminated on June 08, 2017
• Recall Number: Z-0362-2016
• Recall Event ID: 72498
• 510(K)Number: K973164
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.
• Code Information: Multiple Lot Numbers. Catalog Numbers: 6630-6-105, 6630-6-110, 6630-6-125, 6630-6-130, 6630-6-150, 6630-6-155, 6630-6-170, 6630-6-175, 6630-6-205, 6630-6-210, 6630-6-225, 6630-6-230, 6630-6-250, 6630-6-255, 6630-6-270, 6630-6-275, 6630-6-305, 6630-6-310, 6630-6-325, 6630-6-330, 6630-6-350, 6630-6-355, 6630-6-370, 6630-6-375, 6630-6-405, 6630-6-410, 6630-6-425, 6630-6-430, 6630-6-450, 6630-6-455, 6630-6-470 and 6630-6-475.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Mr. Paul Jahnke; 201-831-5826
• Manufacturer Reason for Recall: Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).
• FDA Determined Cause: Under Investigation by firm
• Action: On September 18, 2015, Stryker notified their Branches/Agencies of their action via email. The Branches/Agencies were instructed to quarantine affected devices. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Branches/Agencies via UPS on 9/21/2015. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Hospital Risk Managers via UPS on 9/23/2015. The notification instructed consignees on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Consignees were asked to contact their Stryker Orthopaedics Sales Representative to arrange for return of any recalled product. Customers were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerortho7984@stericycle.com or Fax (1-866-672-0627) the response form back. A point of contact was provided in case the customer had any questions 201.831.5826.
• Quantity in Commerce: 2,577 units
• Distribution: Distributed US (nationwide) and the countries of Australia, Canada, Germany, Hong Kong, Italy, Japan, Malaysia, New Zealand, Netherlands, Poland, Romania, Spain, Sweden and Switzerland.
• 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 = JWH and Original Applicant = HOWMEDICA CORP.