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U.S. Department of Health and Human Services

Class 2 Device Recall Kinemax Stem Extenders

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  Class 2 Device Recall Kinemax Stem Extenders see related information
Date Initiated by Firm February 27, 2015
Date Posted May 14, 2015
Recall Status1 Terminated 3 on October 13, 2016
Recall Number Z-1614-2015
Recall Event ID 70784
510(K)Number K904208  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Kinemax Stem Extenders, 80 mm,
Product Usage:
Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The Kinemax Cemented Stem Extenders are available in three different lengths, 40 mm (Part #6476-8-250), 80mm (Part #6476-8-260) and 155mm (Part #6476-8-270). The 40 mm cemented stem extender is not indicated for use in the MRH system; however, it is indicated for use with the Scorpio TS and Duracon TS systems (LRKS/G Rev. 2). Both the 80mm and 155mm stem extenders are indicated for use in all three systems.
Code Information Catalog No. 6476-8-260, Lot code: EJPLC
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Mr. Paul Jahnke
201-831-5000
Manufacturer Reason
for Recall		 Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Stryker Orthopaedics an Urgent Medical Device Recall Letter/Notification Acknowledgement Form dated April 9, 2015 to their affected customers. The recall letter identified the affected product, problem and actions to be taken. Customers are asked to contact their Stryker Orthopaedics Sales Representative to arrange for return of the product if they have any of the affected items. Customers are asked to complete and return the acknowledgement form within 5 days by emailing to: so_m_product_field_action_response@stryker.com or faxed to: 1-855-251-3635. For question call 201-831-6365.
Quantity in Commerce 4 units
Distribution US Nationwide distribution in the states of MA and RI.
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.
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