Class 2 Device Recall Affixus Hip Fracture Nail

• Date Initiated by Firm: July 17, 2018
• Date Posted: September 13, 2018
• Recall Status: Terminated on June 02, 2020
• Recall Number: Z-3120-2018
• Recall Event ID: 80755
• 510(K)Number: K100238
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number: 814511180
• Code Information: 072620 130760 130770 130780 130790 130800 130810 130820 130840 130850 130860 130900 130920 131030 156770 157000 188340 219800 219810 219820 219910 245570 245690 287090 287120 287130 371170 456160 519490 530110 530120 530130 558980 565870 565880 601390 707920 768050 772730 854270 901300 901330 901350 901360 901370 901380 901400 901410 944660 944720 970790 970810 970820 970830 970840 970850 970860 970870 970880 970890 130930 130940 156970 503980 503990 504000 504010
• 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: The set screw is not able to advance or reverse from the original position in the nail.
• FDA Determined Cause: Under Investigation by firm
• Action: On 7/17/18, Urgent Medical Device Recall letters were sent to Risk Managers and Distributors. The letters instructed customers to do the following: 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. 5. 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. 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. Request a Return Authorization Number through Fast SMS or by emailing rgarequest@zimmerbiomet.com c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. d. Include a hardcopy of Attachment 1 in each carton of
• Quantity in Commerce: 5947 total
• Distribution: The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, 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 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