RecallRadar

FDA Device recall Z-3055-2018

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

On 2018-09-19 the FDA classified a Class II recall of Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180 by Zimmer Biomet, citing the set screw is not able to advance or reverse from the original position in the nail.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-3055-2018
ClassificationClass II
Statusterminated
Initiated2018-07-17
Published2018-09-19
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
DistributionAL, 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, PR, SC, SD, TN, TX, UT, VA, WA, WI, WY

Product

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

Reason

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

Identifiers

code_info
017190 017200 017210 017240 017260 063270 063330 063360 063370 063400 087850 087870 097080 132740 153330…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3055-2018%22

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