RecallRadar

FDA Device recall Z-3157-2018

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360

On 2018-09-19 the FDA classified a Class II recall of Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360 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-3157-2018
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 Left 130¿ 11 mm x 360 mm, Item Number: 814611360

Reason

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

Identifiers

code_info017730 085400 154660 154670 154680 157450 558510 565960 694270 711210 812570 812730 818350 945040 629800

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-3157-2018%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.