Zimmer, Inc.: Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented

Hazard

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.

Details from the source

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. Quantity: 160 units Lot/code info: GTIN 00887868376368, All lots distributed with IFU 87-6204-051-99 Rev D or prior

UPC codes

00887868376368

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.