Zimmer Biomet, Inc. recalls Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments…

Recall date

August 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0083-2017

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.