CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00
Summary
The FDA issued a Class II for CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Ar by Zimmer, Inc.. Reason: Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF..
Details
Source
Device Recall
External ID
Z-2450-2024
Action Date
2024-08-07
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 5,500 (US); 242,000 (OUS)
Reason for Recall
Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-02
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 107 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zimmer, Inc. has 87 FDA actions in our database, including 65 recalls and 22 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zimmer, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zimmer, Inc. have FDA actions?
Zimmer, Inc. has 87 FDA actions in our database, including 65 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2450-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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