RecallRadar

FDA Device recall Z-1510-2026

Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X

On 2026-03-18 the FDA classified a Class II recall of Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X by Exactech, citing impactor handle may be missing cross-pin.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1510-2026
ClassificationClass II
Statusongoing
Initiated2026-02-03
Published2026-03-18
Last updated2026-09-13 11:58 UTC
CompanyExactech
DistributionCA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI

Product

Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X

Reason

Impactor handle may be missing cross-pin

Identifiers

code_infoAll Lots/ UDI-DI: 10885862559166

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1510-2026%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.