Class 2 Device Recall Affixus Hip Fracture Nail Left 125 9 mm x 320 mm

• Date Initiated by Firm: August 08, 2018
• Create Date: October 18, 2018
• Recall Status: Terminated on July 30, 2020
• Recall Number: Z-0147-2019
• Recall Event ID: 81038
• 510(K)Number: K100238
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures
• Code Information: Lot Numbers:558060
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
• FDA Determined Cause: Employee error
• Action: Urgent Medical Device Recall notification letters dated 8/8/18 were sent to customers. The letters identified the affected products, problem and actions to be taken. Customers were instructed to: 1. Complete the 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. 2. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com
• Quantity in Commerce: 14
• Distribution: Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Chile, 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 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 = HSB