FDAFDA · Food and drugs·Recall number Z-1615-2014
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Published May 21, 2014 · Recall initiated: April 22, 2014
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
This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.
- Lot
- Catalog Number: 11-210062 Lot Number Identification: 972230
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.