Zimmer Biomet, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0083-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 9, 2016

Date Posted: October 19, 2016

Recall Number: Z-0083-2017

Event ID: 75234

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.

Status: Terminated

Product Quantity: 31

Code Information:

Item number: 14-442008 Lot number: 2095181

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated