Class 2 Device Recall EMPOWR Locking Femoral Impactor

• Date Initiated by Firm: February 04, 2019
• Date Posted: December 06, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0611-2020
• Recall Event ID: 84151
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
• Code Information: All Lots
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758-5445
• For Additional Information Contact: Teffany Hutto; 512-832-9500
• Manufacturer Reason for Recall: The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain
• FDA Determined Cause: Device Design
• Action: On February 4, 2019, DJO emailed consignees a Urgent Field Safety Notice" concerning the recalled product. This field safety notices provided consignees "best practices" for use of the device. On August 19, 2019, DJO revised their "Urgent Field Safety Notice" to communicate the exchange process for physical product in consignees inventory. The field safety notices asked consignees to take the following actions: 1. Please locate within your inventory part 800-05-035 in FA K EMP COMP PAT TOOL KIT, FA K EMP PAT TOOL KIT, and FA K EMP PAT TOOL KIT WIMPCTR. The quantities shown within each consignee letter is specific to the consignee. 2. Contact Customer Service to initiate a return of the product via RMA and to have the replacement impactors sent to you. 3. If you have any questions, please contact Teffany Hutto by phone at (512) 834-6255 or by email at teffany.hutto@djoglobal.com.
• Quantity in Commerce: 410 devices
• Distribution: CO, WA, CA, UT, CA, TN, TX, MS, MO, AR, OK, LA, MN, IL, IN, KY, OH, MI, PA, SC, FL, PR, AL, GA, NM, AZ, NV, VA, RI, MD, ME PA, NY OUS: None
• 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.