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Recall Observatory FDA recall evidence

Device product

Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180

Z-3055-2018

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-3055-2018

Official wording

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

Code information: 017190 017200 017210 017240 017260 063270 063330 063360 063370 063400 087850 087870 097080 132740 153330 153470 153490 153510 153540 219770 219780 290570 290580 290620 500680 500710 500740 503300 503350 519650 565790 565800 585690 601380 628190 645550 645580 688170 688190 688200 688210 707670 741680 741690 741700 899820 899840 899850 899870 899880 900000

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.