Device recall

Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.

FDA recall source

Recall number

Z-0282-2027

Event id

99968

Status

Ongoing

FDA classification

Class II

Recalling firm

AVID Medical, Inc.

Report date

Oct 28, 2026

Posted

Oct 22, 2026

Initiated

Sep 8, 2026

Center classification date

Oct 22, 2026

Product code

LRO

Device type

General Surgery Tray

Reason

A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.

Root cause

Process control

Quantity

56 kits

Code info

Model/Catalog Number: SOAH31. UDI-DI: 10809160512890. Lot Code: Lot Number: 1689215. Expiration Date: 11/06/2026.

Distribution

US Nationwide distributor in the state of Arizona.

Voluntary or mandated

Voluntary: Firm initiated

Location

Toano, VA, United States