RecallRadar

FDA Device recall Z-3138-2018

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400

On 2018-09-19 the FDA classified a Class II recall of Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400 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-3138-2018
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¿ 13 mm x 400 mm, Item Number: 814513400

Reason

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

Identifiers

code_info152980 482780 530160 798520 798530 798540 773050

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-3138-2018%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.