Class 2 Device Recall NexGen CRFlex Porous Femur

• Date Initiated by Firm: March 28, 2024
• Date Posted: April 22, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1608-2024
• Recall Event ID: 94327
• 510(K)Number: K031061
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
• Code Information: Item No. 00595201501, 00595201502, 00595201505, 00595201506; UDI:(01)00889024207806(17)280731(10)64115713, (01)00889024207806(17)280930(10)64175075, (01)00889024207806(17)280930(10)64175076, (01)00889024207790(17)280930(10)64175073, (01)00889024207806(17)280930(10)64138317, (01)00889024207790(17)281031(10)64175074, (01)00889024207790(17)281031(10)64194991, (01)00889024207790(17)281031(10)64202116, (01)00889024207806(17)281031(10)64178998, (01)00889024207813(17)281031(10)64179054, (01)00889024207790(17)281031(10)64202117, (01)00889024207813(17)281031(10)64179043, (01)00889024207813(17)281031(10)64194989, (01)00889024207790(17)281031(10)64178996, (01)00889024207790(17)281031(10)64178997, (01)00889024207790(17)281031(10)64179023, (01)00889024207820(17)281031(10)64178999, (01)00889024207813(17)281031(10)64179043R, (01)00889024207813(17)281031(10)64194989R, (01)00889024207790(17)281130(10)64202115, (01)00889024207790(17)281130(10)64226003, 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• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
• FDA Determined Cause: Process change control
• Action: Consignees were sent an URGENT MEDICAL DEVICE RECALL notification dated 3/28/24. Distributors are to review the provided notification, notify the appropriate team members of the contents of the notification, locate and quarantine affected product in your inventory, return all affected product from the respective distributorship and affected hospitals to Zimmer by submitting an Inventory Return Certification Form to CorporateQuality.PostMarket@zimmerbiomet.com (international returns are to be coordinated by emailing zimmerbiometintlirarequests@zimmerbiomet.com), and retain a copy of the Inventory Return Certification and product returns forms. Risk Managers are to review the provided notification, notify the appropriate team members of the contents of the notification, locate and quarantine affected product in your inventory with the assistance of a Zimmer Biomet sales representative, the Zimmer Biomet sales representative will remove affected devices from consignee facilities, return the provided Certificate of Acknowledgement to CorporateQuality.PostMarket@zimmerbiomet.com, and retain a copy of the acknowledgement form for your records. Surgeons are to review the provided notification, complete the provided Certificate of Acknowledgement to CorporateQuality.PostMarket@zimmerbiomet.com, retain a copy of the acknowledgement form for your records; there is no specific patient monitoring instructions related to this recall. Consignees with any questions are to contact Customer Service at 574-371-3071 from Monday through Friday between the hours of 8:00 am and 5:00 pm EST.
• Quantity in Commerce: 5,546 units
• Distribution: Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the countries of Australia, Canada, Japan, Netherlands.
• 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 = JWH and Original Applicant = ZIMMER, INC.