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U.S. Department of Health and Human Services

Class 2 Device Recall Phoenix Femoral Nail System

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  Class 2 Device Recall Phoenix Femoral Nail System see related information
Date Initiated by Firm August 09, 2016
Date Posted October 14, 2016
Recall Status1 Terminated 3 on March 23, 2017
Recall Number Z-0083-2017
Recall Event ID 75234
Product Classification Guide, surgical, instrument - Product Code FZX
Product Phoenix Recon Soft Tissue Sleeve
Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm

Product Usage:
The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. These instruments are used in support of the surgery.
Code Information Item number: 14-442008 Lot number: 2095181
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Customer Service
800-348-2759
Manufacturer Reason
for Recall		 Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm. Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.
FDA Determined
Cause 2		 Finished device change control
Action On 8/9/2016, URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions or concerns call the customer call center at 1-800-348-9500 ext 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com.
Quantity in Commerce 31
Distribution US Nationwide Distribution in the states of: MI, UT, SD, OH, WA, KS, MO, NJ, GA, and TX.
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.
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