Class 2 Device Recall EMPOWR Acetabular System

• Date Initiated by Firm: September 09, 2020
• Create Date: October 20, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0135-2021
• Recall Event ID: 86450
• 510(K)Number: K190057
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.
• Code Information: Model Number: 940-02-54G Lot Number: 801Z1036
• Recalling Firm/ Manufacturer: Encore Medical, LP; 9800 Metric Blvd; Austin TX 78758-5445
• For Additional Information Contact: Teffany Hutto; 512-834-6255
• Manufacturer Reason for Recall: Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.
• FDA Determined Cause: Employee error
• Action: On 09/11/2020, the firm sent out an email containing an "URGENT FIELD SAFETY NOTICE" to it Surgical/Sales Agents informing them that a product complaint was received stating that a surgeon had issues with implanting the device and stated that "too tight even after reaming line-to-line" and that the affected device did not seat properly. The Recalling Firm was notifying its agents to immediately return all unused affected devices and pointed out that the risks associated with this issue include the following: -Lack of cup fixation -Device loosening -Fracture -Pain -Delay in Surgery -Revision Surgery. Customers were also to perform the following actions by September 25, 2020: 1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. 2. Review your stock for the affected products and lot numbers and to 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. Report any adverse events related to this issue to Customer Service. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. For any further questions, contact Teffany Hutto at teffany.hutto@djoglobal.com and/or contact Customer Service at 1-800-456-8696
• Quantity in Commerce: 12 cups
• Distribution: U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.
• 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.