Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prost...
FDA Recall #Z-1645-2025 — Class II — March 24, 2025
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
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.
Recalling Firm
Zimmer, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
416 units
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
Code Information
GTIN 00887868376320, All lots distributed with IFU 87-6204-051-99 Rev D or prior
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated