Drug & Device Safety Atlas
Class II FDA device recall · Z-2450-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426 00811400430 00811400500 00811400510 00811400530 00811401218 00811401318 00811404000 00811405000

Why it was recalled

Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information
Item Number / UDI-DI 00811400000 / 00889024145733 00811400010 / 00889024145740 00811400100 / 00889024145757 00811400110 / 00889024145764 00811400200 / 00889024145771 00811400210 / 00889024145788 00811400218 / 00889024145795 00811400230 / 00889024145801 00811400300 / 00889024145818 00811400310 / 00889024145825 00811400318 / 00889024145832 00811400330 / 00889024145849 00811400400 / 00889024145856 00811400410 / 00889024145863 00811400420 / 00889024145870 00811400423 / 00889024145887 00811400426 / 00889024145894 00811400430 / 00889024145900 00811400500 / 00889024145917 00811400510 / 00889024145924 00811400530 / 00889024145931 00811401218 / 00889024145948 00811401318 / 00889024145955 00811404000 / 00889024145962 00811405000 / 00889024145979

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide - US Nationwide distribution.

Recall record

Recalling firm
Zimmer, Inc.
Product type
Devices
Recall number
Z-2450-2024
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Warsaw, IN
Recall initiated
2024-07-02

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2450-2024 · Source: openFDA enforcement.