Class 2 Device Recall Reflection Interfit Shell, 52 MM OD, 3 HOLE

• Date Initiated by Firm: January 23, 2014
• Date Posted: February 21, 2014
• Recall Status: Terminated on November 15, 2016
• Recall Number: Z-1066-2014
• Recall Event ID: 67404
• 510(K)Number: K960094
• Product Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous - Product Code MBL
• Product: Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. ; Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.
• Code Information: Batch No. 13EM03053
• Recalling Firm/ Manufacturer: Smith & Nephew Inc; 1450 E. Brooks Rd; Memphis TN 38116
• For Additional Information Contact: Joe Metzger; 978-749-1330
• Manufacturer Reason for Recall: Inner spherical radius of the shell is undersized.
• FDA Determined Cause: Under Investigation by firm
• Action: Smith & Nephew Inc. sent an Urgent - Product Recall 1st Notification letter dated January 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions for Hospital Representatives: 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. 2. Complete the last two columns in the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned, and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return . 3. Please contact Smith & Nephews Safety Affairs Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number. 4. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment. Actions for Smith & Nephew Inventory Specialists 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, cease distribution and use of those products, and quarantine them immediately. 2. Carry out a physical count of all affected product in your territory and record this data on the Inventory Return Certification Form on the following page. 3. If you do not have product to return, please place an x in the column No Product to Return , and then fill in the Acknowledgement of Responsibility at the bottom of the form. 4. Fax a copy of the completed Inventory Return Certification Form to: +1-901-566-7975 5. If you have affected products, return the product, along with the completed Inventory Return Certification Form, to the address indicated
• Quantity in Commerce: 10 units
• Distribution: Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.
• 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 = MBL and Original Applicant = SMITH & NEPHEW RICHARDS, INC.