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Recall Observatory FDA recall evidence

Device product

Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 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.

Z-0452-2019

October 02, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 81223
Status
Terminated
Classification
Class II
Quantity
2,163 in total (expanded)
Official record key
device-enforcement:Z-0452-2019

Official wording

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

Code information: Lot number 145060 901680 901690

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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