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U.S. Department of Health and Human Services

Class 2 Device Recall CORAIL Cementless Femoral Stem HA Coated

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  Class 2 Device Recall CORAIL Cementless Femoral Stem HA Coated see related information
Date Initiated by Firm June 21, 2018
Create Date October 11, 2018
Recall Status1 Terminated 3 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/
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Ms. Kim Long
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 2
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.