Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0454-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.

Product Classification:

Class II

Date Initiated: October 2, 2018

Date Posted: November 21, 2018

Recall Number: Z-0454-2019

Event ID: 81223

Reason for Recall:

The set screw is not able to advance or reverse from the original position in the nail.

Status: Terminated

Product Quantity: 2,163 in total (expanded)

Code Information:

Lot number 901770

Distribution Pattern:

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated