Z-2366-2023Class II

Total Hip Kit, REF DYNJ903275S; surgical convenience kit

Name: Z-2366-2023 Total Hip Kit, REF DYNJ903275S; surgical convenience kit
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-07-03
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-07-03 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Total Hip Kit, REF DYNJ903275S; surgical convenience kit on 2023-07-03. FDA classified it as Class II and gives the reason as "The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2366-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-03
Posted: 2023-08-10
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Total Hip Kit, REF DYNJ903275S; surgical convenience kit
Product code: OJH Orthopedic Tray
Reason for recall: The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 16 kits
Distribution: US Nationwide distribution in the state of Illinois.
Product codes and lots: UDI/DI: 10195327254582 (unit), 40195327254583 (case); Lot code 23CDC733

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2366-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2366-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-10

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)