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U.S. Department of Health and Human Services

Class 2 Device Recall The Affixus Hip Fracture Nail System

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  Class 2 Device Recall The Affixus Hip Fracture Nail System see related information
Date Initiated by Firm October 02, 2018
Create Date November 14, 2018
Recall Status1 Terminated 3 on June 02, 2020
Recall Number Z-0453-2019
Recall Event ID 81223
510(K)Number K100238  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165

The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
Code Information Lot number 558260 558270
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 2		 Mixed-up of materials/components
Action The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL  LOT SPECIFIC" notification letters dated 10/2/18 to customers. The letters described the product, problem and actions to be taken. The customers were instructed to 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 or fax to 574-372-4265 . 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.
Quantity in Commerce 2,163 in total (expanded)
Distribution Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and 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 and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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