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U.S. Department of Health and Human Services

Class 2 Device Recall EMPOWR Acetabular System

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  Class 2 Device Recall EMPOWR Acetabular System see related information
Date Initiated by Firm August 12, 2022
Date Posted October 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-0125-2023
Recall Event ID 90882
510(K)Number K190057  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Code Information UDI-DI/Lot: 00190446309833/629Z1085
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
Action On 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 Commerce 4
Distribution US Nationwide distribution in the states of FL, IN, IL, KY, AZ, 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 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 = LPH and Original Applicant = Encore Medical, L.P.
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