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U.S. Department of Health and Human Services

Class 2 Device Recall Femoral Stem

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 Class 2 Device Recall Femoral Stemsee related information
Date Initiated by FirmMay 14, 2018
Create DateAugust 31, 2018
Recall Status1 Terminated 3 on August 17, 2020
Recall NumberZ-2967-2018
Recall Event ID 80692
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductFoundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
Code Information All. Lots-866A1011, 866A1022 
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
FDA Determined
Cause 2		No Marketing Application
ActionThe firm, DJO, sent an "URGENT FIELD SAFETY NOTICE" letter dated 5/14/2018 to it's customers via email, on May 14, 2018 and contained the following information: Description of Issue, Quantity in Field, product information and code, Action required, and an Acknowledgement form with contact information. The customers were instructed to: check your inventory for part number 220-10-110; Customer Service has already requested that these be quarantined by your agency; Contact Customer Service to request an RMA for return of these devices. As there are no currently cleared 10x100 femoral stem extensions, there is no product available for replacement; and complete the attached acknowledgment form, even if you do not have the affected product, and email the form to sandra.busick@djoglobal.com by May 18, 2018. Modular Femoral Cemented Stem -- 220-10-110 -determined that this device does not have FDA clearance. If you have any questions, please contact Manager, Regulatory Affairs at (512) 834-6255 or by email at teffany.hutto@djoglobal.com.
Quantity in Commerce12
DistributionU.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.
Total Product Life CycleTPLC 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.
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