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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 Systemsee related information
Date Initiated by FirmOctober 22, 2019
Create DateMay 08, 2020
Recall Status1 Open3, Classified
Recall NumberZ-1929-2020
Recall Event ID 85376
510(K)NumberK190057 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductEMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis, correction of functional deformity, femoral fracture, and in the salvage of previously failed surgical attempts.
Code Information All lots
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-834-6200
Manufacturer Reason
for Recall		The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.
FDA Determined
Cause 2		Device Design
ActionThe firm requested its agents to identify and return affected devices.
Quantity in Commerce86 units
DistributionUS Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.
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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