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U.S. Department of Health and Human Services

Class 2 Device Recall EMPOWR 3D Knee Tibial Insert

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  Class 2 Device Recall EMPOWR 3D Knee Tibial Insert see related information
Date Initiated by Firm May 12, 2021
Create Date July 20, 2021
Recall Status1 Open3, Classified
Recall Number Z-2104-2021
Recall Event ID 87942
510(K)Number K143242  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Code Information Lot # 155T1035
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Kiersten Soderman
864-322-3801
Manufacturer Reason
for Recall		 Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On 5/12/2021, Encore Medical, LP (DJO) issued a "Urgent Field Safety Notice" via E-Mail. In addition to informing consignees about the recalled product the firm asked consignees to take the following actions by May 26, 2021: 1. This notice needs to be passed on to all those within your organization or to any outside organization or customer where the potentially affected product has been transferred. This recall should be carried out to the user level. 2.Review your stock for the affected products and lot numbers and quarantine the items until returned. 3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. 5. Complete Field Safety Notice Consignee Reconciliation Form (Attachment 1) and return to DJO by May 26, 2021 (see return instructions in Attachment 1) 6. Report any adverse events related to this issue to Customer Service. Your actions above will demonstrate that you have received and understand this notification. Your assistance is appreciated and necessary to prevent the potential health hazards noted above. 7. If you have any questions, please contact Kiersten Soderman at 864-322-3801 or kiersten.soderman@djoglobal.com.
Quantity in Commerce 10 units
Distribution US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ENCORE MEDICAL, L.P.
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