Class 2 Device Recall Zimmer Segmental System, ZSS Distal Femur.

• Date Initiated by Firm: August 01, 2017
• Create Date: February 26, 2018
• Recall Status: Terminated on March 18, 2020
• Recall Number: Z-0721-2018
• Recall Event ID: 78762
• 510(K)Number: K070978
• Product Classification: Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
• Product: Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: ; a. Size B-LT (Item No. 00585001201); ; b. Size B-RT (Item No. 00585001202); ; c. Size C-LT (Item No. 00585001301); ; d. Size C-RT (Item No. 00585001302); ; Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.
• Code Information: a. Item No. 00585001201 (Lot Expiration Date Before 07/31/2026); b. Item No. 00585001202 (Lot Expiration Date Before 07/31/2026); c. Item No. 00585001301 (Lot Expiration Date Before 08/31/2026); d. Item No. 00585001302 (Lot Expiration Date Before 07/31/2026)
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 574-267-6131
• Manufacturer Reason for Recall: The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
• FDA Determined Cause: Package design/selection
• Action: The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL"-Lot Specific letter dated 8/1/2017 to its Customers via email and/or FedEx. The letter describes the product, problem and actions to be taken. The Instructions to Distributors, Sales Representatives, and Distributor Operation Managers included to ensure affected team member are aware of the contents of the notification letter, immediately locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement form by email to: corporatequality.postmarket@zimmerbiomet.com., return all affected product, and note if there are any hospitals and/or surgeons for which need to be notified. Instructions for Risk Managers and surgeons are to ensure affected personnel are aware of the contents of the notification letter, quarantine any affected product on hand, complete and return the Certificate of Acknowledgement form by email to: corporatequality.postmarket@zimmerbiomet.com., and return any affected product on hand. For questions or concerns, please call the 411 call center at 1-574-371-3071 between 8:00 am and 5:00 pm EST, Monday through Friday or email corporatequality.postmarket@zimmerbiomet.com
• Quantity in Commerce: 3,350 units total
• Distribution: Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.
• 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 = KRO and Original Applicant = ZIMMER, INC.