Class 2 Device Recall CORAIL Cementless Femoral Stem HA Coated

• Date Initiated by Firm: June 21, 2018
• Create Date: October 11, 2018
• Recall Status: Terminated on April 06, 2020
• Recall Number: Z-2521-2018
• Recall Event ID: 80240
• 510(K)Number: K042992 K123991
• Product Classification: Prosthesis, hip, hemi-, femoral, metal - Product Code KWL
• Product: CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
• Code Information: 5307603 5300997
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: Ms. Kim Long; 574-371-4917
• Manufacturer Reason for Recall: Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
• FDA Determined Cause: Process control
• Action: On June 21, 2018, the firm issued an Urgent Information: US Recall Notice via email to affected customers. Medical professionals were asked to do the following: " Cease using the affected components immediately. " Immediately return unused affected units: Medical facilities are to determine if any of the recalled components are still on hand, and return affected devices immediately to their DePuy Sales Consultant or return them to DePuy for credit following normal purchasing procedures. Reconciliation forms should be faxed to 574-371-4939. " Reconciliation Form: Complete the Reconciliation Form and return to your DePuy Synthes Sales Consultant or fax to 574-371-4939 within five (5) days of this notice. " Records: Retain a copy of the completed Reconciliation Form in your files along with this notice. " Additional Notifications: Notify surgeon users at your facility by providing them with a copy of this notice to ensure surgeon users are aware of this recall notice. Forward this notice to others in your facility that need to be informed. " Maintain a copy of this notice with the affected devices. For questions about device recall information provided, please contact Kim Long, Senior Recall Coordinator, at 574-371-4917 or klong16@its.jnj.com. U.S. Distributors and Sales Offices received a separate notice with specific instructions on how to identify, remove, and return the affected devices.
• Distribution: Accounts in AL, CA, CO, GA< IL, LA, ME, NC, NH, NY, OR, TX, UT, and WA. Foreign distribution to Belgium, Croatia, Cyprus, Denmark, Germany, Indonesia, Korea, Sweden, and Tunisia.
• 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 = KWL and Original Applicant = DEPUY FRANCE S.A.S.; 510(K)s with Product Code = KWL and Original Applicant = DEPUY ORTHOPAEDICS, INC.