RecallRadar

FDA Device recall Z-0304-2023

regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023

On 2022-11-30 the FDA classified a Class II recall of regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023 by Roi Cps, citing surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0304-2023
ClassificationClass II
Statusterminated
Initiated2022-10-20
Published2022-11-30
Last updated2026-09-13 11:56 UTC
CompanyRoi Cps
DistributionFL, LA, MO, NC

Product

regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit

Reason

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Identifiers

code_infoUDI/DI 10194717113911, Lot Numbers: 91560, exp 12/7/2023; 92467, exp 2/14/2024

Status history

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

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0304-2023%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.