Class 2 Device Recall THP Hip Plating System

• Date Initiated by Firm: January 07, 2020
• Date Posted: January 29, 2020
• Recall Status: Terminated on April 08, 2021
• Recall Number: Z-1347-2020
• Recall Event ID: 84753
• 510(K)Number: K140018
• Product Classification: Device, fixation, proximal femoral, implant - Product Code JDO
• Product: THP Hip Plating System, Item Nos. 14-451070; 14-451075; 14-451080; 14-451085; 14-451090; 14-451095; 14-451100; 14-451105; 14-451110; 14-451115; 14-451120; 14-451125; 14-451130; .; ; The product is a metallic bone fixation system.
• Code Information: Lots 397440 875130 018810 018850 018860 018880 018900 030090 030100 030140 030150 030180 049860 049870 049900 096520 108200 108290 129340 129420 129440 129460 129500 129520 129550 129570 129580 129590 129600 129620 142280 142290 142310 348480 397350 397370 397400 397430 407250 407260 407270 434970 434980 527970 527990 552890 553000 606240 606260 606300 613290 613300 613310 613320 613330 613340 613350 613360 613380 613390 651570 784830 784840 788980 801670 801720 801780 801820 801840 801860 801870 801990 802020 802030 802050 807500 807520 807530 807540 807550 807560 807580 807590 807660 807680 807720 829230 829250 829270 829290 829300 829310 829320 829350 829370 833790 833810 833830 833880 833930 833950 875050 875060 875100 875110 875120 875150 875160 878040 878070 878210 878220 878240 878320 878340 879530 879540 879550 879560 879590 879600 879610 879640 879660 879680 879720 879740 879750 879780 958600 958610 964340 971780 971790 971810 971860 971910 971930 971940 971960 971980 972010 972050 979520 979590 979640 979810 980040
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Customer Service; 574-371-3071
• Manufacturer Reason for Recall: Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
• FDA Determined Cause: Under Investigation by firm
• Action: On January 7, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to take the following actions: 1. Review the recall information 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. The sales representative will remove the affected product from your facility. 3. There are no specific patient monitoring instructions related to this recall that are recommended beyond the existing follow-up schedule. IF there is a device fracture, it can be detected through x-rays. 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: 1662
• Distribution: Domestic distribution to AL CA FL IA IL MD MI MN MO MS NC NE NJ NY PA TX UT VA WA WI
• 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 = JDO and Original Applicant = BIOMET, INC.