FDAFDA · Food and drugs·Recall number Z-0386-2013
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Published November 28, 2012 · Recall initiated: August 27, 2012
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
Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- USA (nationwide) including the states of Ohio, Carolinas and New England.
- Lot
- Item 00-6334-062-36, Lot 62023769
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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