Class 2 Device Recall Zimmer Biomet

• Date Initiated by Firm: April 16, 2019
• Create Date: May 28, 2019
• Recall Status: Terminated on May 19, 2020
• Recall Number: Z-1494-2019
• Recall Event ID: 82726
• Product Classification: Table, surgical with orthopedic accessories, manual - Product Code JEB
• Product: Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item Number: 00-1320-010-00 Alvarado Knee Holder Base Plate Assembly: Item Number: 00-1320-011-00 Alvarado II Foot Piece: Item Number: 00-1320-210-00 Alvarado II Base Plate: Item Number: 00-1320-211-00 Product Usage: This device is designed to hold the patient s knee in the selected position during surgery. The Alvarado Knee Holder includes a Base Plate assembly with two rows of slotted hooks. These rows extend upward from the base plate for a sufficient length to provide adequate selective adjustment. A Foot Piece is mounted on an alignment rod that is pivotally engaged into the hook portion of the slots.
• Code Information: All lot codes
• Recalling Firm/ Manufacturer: Zimmer Surgical Inc; 200 W Ohio Ave; Dover OH 44622-9642
• For Additional Information Contact: SAME; 330-343-8801
• Manufacturer Reason for Recall: Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate and Foot Piece due to potentially inadequate cleaning procedures
• FDA Determined Cause: Device Design
• Action: Zimmer Biomet issued letter on 4/10/19 via email to distributors; and Hospital risk managers, as well as distributors with product notified via courier. Distributors letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have unconsumed inventory on hand. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Locating and returning the product in their territory. - Returning Attachment 1 (Certificate of Acknowledgement) to Zimmer Biomet. Questions or concerns after reviewing this notice, please call customer service at 800-830-0970 between 8:00 am and 5:00pm EST, Monday through Friday. Updates to the FAQ (clarification) sent via email on April 19 to distributors.
• Quantity in Commerce: 37,402
• Distribution: Worldwide distribution - US Nationwide and countries of AUKLAND AUSTRALIA BRAZIL CANADA CHILE Dominican Republic EL SALVADOR GUATEMALA HONG KONG INDIA JAPAN MEXICO NETHERLANDS NEW ZEALAND KOREA SINGAPORE TAIWAN VENEZUELA
• 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.