Class 2 Device Recall Stryker Orthopaedics

• Date Initiated by Firm: June 25, 2015
• Date Posted: September 23, 2015
• Recall Status: Terminated on August 30, 2017
• Recall Number: Z-2810-2015
• Recall Event ID: 71754
• 510(K)Number: K033716
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
• Code Information: Lot Code 3Y0KHP
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Ms. Aminah Crawford; 201-831-5000
• Manufacturer Reason for Recall: it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Stryker Orthopaedics notified their branches via email on 6/25/2015. Notification letters and Product Accountability Forms were mailed to Stryker Branches/Agencies on 817/2015 and hospital risk management on 8/18/2015.
• Quantity in Commerce: 16 units
• Distribution: Distributed in WI.
• 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 = LPH