FDAFDA · Food and drugs·Recall number Z-0626-2018
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.
Published February 21, 2018 · Recall initiated: August 25, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- US Nationwide Distribution
- Lot
- Item #110024464 Lot# 478340
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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