Recalls / —

—#202345

Product

Total Hip Kit, REF DYNJ903275S; surgical convenience kit

FDA product code

OJH — Orthopedic Tray

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

UDI/DI: 10195327254582 (unit), 40195327254583 (case); Lot code 23CDC733

Why it was recalled

The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline notified its sole consignee by email on 07/07/2023, The consignee was instructed to destroy any affected product that they may have on hand.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide distribution in the state of Illinois.

Timeline

Recall initiated

2023-07-03

Posted by FDA

2023-08-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202345. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.