—#149727

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.

FDA product code: FZX — Guide, Surgical, Instrument
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Item number: 14-442008 Lot number: 2095181

Why it was recalled

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.

Root cause (FDA determination)

Finished device change control

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US Nationwide Distribution in the states of: MI, UT, SD, OH, WA, KS, MO, NJ, GA, and TX.

Timeline

Recall initiated: 2016-08-09
Posted by FDA: 2016-10-14
Terminated: 2017-03-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149727. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.