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U.S. Department of Health and Human Services

Class 2 Device Recall EMPOWER 3D Knee Tibial Insert

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 Class 2 Device Recall EMPOWER 3D Knee Tibial Insertsee related information
Date Initiated by FirmAugust 12, 2022
Date PostedOctober 21, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0126-2023
Recall Event ID 90882
510(K)NumberK143242 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductEMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Code Information UDI-DI/Lot: 00888912167055/132T1085
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-834-6200
Manufacturer Reason
for Recall		Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
FDA Determined
Cause 2		Process control
ActionOn 8/12/22, recall notices were emailed to DJO Surgical Agents who were informed to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected devices have been transferred. 2) Return affected devices 3) Complete and return the response form Questions, contact: Julie.Baker@Enovis.com
Quantity in Commerce18
DistributionUS Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
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 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) Database510(K)s with Product Code = LPH
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