Class 2 Device Recall DePuy

• Date Initiated by Firm: June 29, 2022
• Create Date: July 20, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1419-2022
• Recall Event ID: 90557
• Product Classification: Template - Product Code HWT
• Product: ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
• Code Information: GTIN: 10603295434061 Lots: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: SAME; 574-267-8143
• Manufacturer Reason for Recall: Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
• FDA Determined Cause: Process control
• Action: DePuy Synthes issued Urgent Medical Device Correction Letter on June 29 2022. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately for the subject lots and quarantine the products. 2. To minimize disruption, replacement of the spring will be completed by a Field Service Representative. You will be contacted directly by a member of the Field Service Team. 3. Familiarize yourself with the content of this letter and forward this notice to any personnel in your facility who need to be informed. 4. Complete all fields, sign, and return the attached business response form (BRF) on the last page of this letter to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this medical device correction letter. Please include FA 2126657 - Attune Measured Sizing & Rotation Guide in the email subject line. 5. Complete the BRF even if you do not have any of the subject product in your current inventory. 6. If any of the subject product has been forwarded to another facility, contact that facility, and provide a copy of this notice to the relevant personnel. 7. Post a copy of this notice in a visible area for awareness of this correction. Contact your local DePuy Synthes Sales Consultant. For Medical Information Requests, please visit our website: https://www.jnjmedicaldevices.com/mir
• Quantity in Commerce: 872 units
• Distribution: Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.