FDA recall Z-1646-2025

Zimmer, Inc. · Class II · device

Product

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; 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.

Distribution

Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.

Key facts

Status: Ongoing
Initiation date: 2025-03-24
Report date: 2025-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1646-2025