Class 2 Device Recall NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED

• Date Initiated by Firm: November 29, 2017
• Create Date: March 14, 2018
• Recall Status: Terminated on April 02, 2020
• Recall Number: Z-1034-2018
• Recall Event ID: 78706
• 510(K)Number: K960279
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: LPS FEM IMPLANT SZ H-R; ; This device is indicated for patients with severe knee pain and disability
• Code Information: 00-5996-018-92 61836677
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: Kevin W. Escapule; 574-372-4487
• Manufacturer Reason for Recall: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
• FDA Determined Cause: Packaging
• Action: A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag. A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additi
• Quantity in Commerce: 13,227 in total
• Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
• 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 = JWH and Original Applicant = ZIMMER, INC.