RecallRadar

FDA Device recall Z-3126-2018

Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360

On 2018-09-19 the FDA classified a Class II recall of Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360 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-3126-2018
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 Right 130¿ 11 mm x 360 mm, Item Number: 814511360

Reason

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

Identifiers

code_info107830 107850 152910 154990 482740 519610 565900 707960 762780 773410 812310 812330 097190 696380

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-3126-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.