Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constr
Summary
The FDA issued a Class II for Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number by Zimmer, Inc.. Reason: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobal.
Details
Source
Device Recall
External ID
Z-1645-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
Product Description
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Lot/Code Info: GTIN 00887868376320, All lots distributed with IFU 87-6204-051-99 Rev D or prior
Quantity Affected: 416 units
Reason for Recall
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-24
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 193 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-1645-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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