Recall Z-0084-2017— Zimmer Biomet, Inc.

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-08-09, terminated 2017-03-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Phoenix Recon Targeting Arm 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.. Reason: 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..

Recalling firm

Zimmer Biomet, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-08-09

Terminated

2017-03-23

Firm location

Warsaw, IN, United States

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