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.

Recall Initiated

September 9, 2020

Recall Number

Z-0135-2021

Quantity

12 cups

Firm Location

Austin, TX

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.

Distribution

U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.

Lot / Code Info

Model Number: 940-02-54G Lot Number: 801Z1036

Root Cause

Employee error

Action Taken

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