Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall DePuy ATTUNE REVISION DISTAL FEMORAL AUGMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall DePuy ATTUNE REVISION DISTAL FEMORAL AUGMENT see related information
Date Initiated by Firm January 05, 2022
Create Date February 09, 2022
Recall Status1 Terminated 3 on December 22, 2023
Recall Number Z-0632-2022
Recall Event ID 89454
510(K)Number K160700  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries
Product Number: 154706001
Code Information Lots: JJ3389 GTIN: 10603295382775
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		 May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DePuy Synthesis issued Urgent Medical Device Recall Letter dated 1/5/22. Letter states reason for recall, health risk and action to take: 1. Carefully review the information contained in this notice. 2. Return the subject products using the normal returns process. Work with your sales consultant to ensure that the products are returned and to arrange for a replacement. To receive replacement product or reimbursement, customers must return the products subject to this notice. 3. Complete all fields of the attached Business Response Form. Please make sure to include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. The Business Response Form (BRF) must be completed and returned even if no subject product is in your possession. 4. Forward this notice to any personnel in your facility who need to be informed. 5. If any of the products subject to this notice have been forwarded to another facility, contact that facility and provide a copy of this notice to the relevant personnel. 6. Post a copy of this notice in a visible area for awareness of this notice. 7. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda. If you have any questions, please contact your local DePuy Synthes Sales Consultant.
Quantity in Commerce 3 units
Distribution US Nationwide distribution in the states of TN, TX.
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 = JWH and Original Applicant = Depuy (Ireland)
-
-