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Total Hip Kit, REF DYNJ903275S recallZ-2366-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Jul 3, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2366-2023
Status
Open, Classified
Initiated by the company
Jul 3, 2023
Posted by the FDA
Aug 10, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
16 kits
Product code
OJH
Distribution
US Nationwide distribution in the state of Illinois.

Product description

Total Hip Kit, REF DYNJ903275S; surgical convenience kit

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page