Skip to content
Recall Observatory FDA recall evidence

Device product

Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180

Z-3047-2018

July 17, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 80755
Status
Terminated
Classification
Class II
Quantity
5947 total
Official record key
device-enforcement:Z-3047-2018

Official wording

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

Code information: 017090 017100 017110 017120 063130 063190 188050 188080 188090 219720 219730 219740 219750 290520 290550 331360 371020 371060 455870 455890 530040 530060 530080 541100 559250 559260 559270 559290 688160 706780 899800 944420 530030 530090

Distribution pattern: The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, 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.