Class 2 Device Recall AltiVate Reverse Small Socket Insert

• Date Initiated by Firm: August 31, 2020
• Create Date: October 16, 2020
• Recall Status: Terminated on April 19, 2024
• Recall Number: Z-0117-2021
• Recall Event ID: 86395
• 510(K)Number: K172351
• Product Classification: Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
• Product: AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
• Code Information: Lot Number: 964W1000
• Recalling Firm/ Manufacturer: Encore Medical, LP; 9800 Metric Blvd; Austin TX 78758-5445
• For Additional Information Contact: 512-834-6200
• Manufacturer Reason for Recall: Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
• FDA Determined Cause: Labeling False and Misleading
• Action: On 08/31/2020, the firm notified affected customers via email using a letter titled, "URGENT FIELD SAFETY NOTICE", indicating the following: The firm requires that you do the following actions by September 11, 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 using the RMA number. Your actions above will demonstrate that you have received and understand this notification. If you have any questions, please contact the company's Regulatory Affairs Manager via email. Company telephone number is 1-800-321-9549.
• Quantity in Commerce: 15
• Distribution: US Nationwide distribution.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWS