FDAFDA · Food and drugs·Recall number Z-1906-2018
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Published May 30, 2018 · Recall initiated: March 30, 2018
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 were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
- Lot
- Batch Numbers: 11DM11664 & 15BM09445
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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