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U.S. Department of Health and Human Services

Class 2 Device Recall 3DKnee HXL Tibial Insert

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  Class 2 Device Recall 3DKnee HXL Tibial Insert see related information
Date Initiated by Firm May 31, 2017
Create Date June 30, 2017
Recall Status1 Terminated 3 on January 08, 2021
Recall Number Z-2658-2017
Recall Event ID 77435
510(K)Number K091956  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01,

The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
Code Information Lot # 292G1910
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Neeta Sharma
760-734-3551
Manufacturer Reason
for Recall		 Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
FDA Determined
Cause 2		 Packaging process control
Action The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" dated 5/31/2017 by email to its consignees on 5/31/2017. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following actions by June 16, 2017: pass notice on to all those within the organization or to any organization where the affected product has been transferred; contact customer service at 1-800-456-8696 to place a replacement order and obtain shipment information; return all affected devices; and complete, sign and return the Acknowledgment and Receipt Form by email to: Desiree.Wells@djoglobal.com. The Regulatory Affairs department will follow-up via phone and email with non-responding consignees. If you have any questions, please contact Sr. Director Regulatory Affairs by phone at (760) 734-3551 or by email at Neeta.Sharma@djoglobal.com.
Quantity in Commerce 9 units
Distribution Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
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 = ENCORE MEDICAL, L.P.
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