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U.S. Department of Health and Human Services

Class 2 Device Recall Affixus Hip Fracture Nail Right 125 9 mm x 440 mm

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  Class 2 Device Recall Affixus Hip Fracture Nail Right 125 9 mm x 440 mm see related information
Date Initiated by Firm August 08, 2018
Create Date October 18, 2018
Recall Status1 Terminated 3 on July 30, 2020
Recall Number Z-0129-2019
Recall Event ID 81038
510(K)Number K100238  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440

Product Usage:
Intended for the fixation of fractures

Code Information Lot Numbers: 289130 
Recalling Firm/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
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 2
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 and Original Applicant = DEPUY ORTHOPAEDICS, INC.