FDAFDA · Food and drugs·Recall number Z-0442-2013
Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.
Published December 5, 2012 · Recall initiated: November 6, 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
It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Nationwide distribution: USA including states of: AZ, MD, and KS.
- Lot
- Catalog Number: 192411 and Lot Number Identification: 244800
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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