RecallRadar

FDA Device recall Z-1573-2022

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

On 2022-08-31 the FDA classified a Class II recall of HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 by Mizuho Osi, citing one batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1573-2022
ClassificationClass II
Statusongoing
Initiated2021-07-29
Published2022-08-31
Last updated2026-09-13 11:56 UTC
CompanyMizuho Osi
DistributionUS

Product

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

Reason

One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

Identifiers

code_infoModel Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1573-2022%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.