FDA-Device2018-02-21Class II

G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.

Zimmer Biomet, Inc.
Hazard

The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.

Sold states
US Nationwide Distribution
Affected count
8
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0626-2018

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