FDAFDA · Food and drugs·Recall number Z-0514-2015
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Published December 17, 2014 · Recall initiated: October 17, 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
Laser etching on the parts is wider and deeper than the conditions previously validated.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet Microfixation, LLC
- Distributor
- Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
- Lot
- Model 24-6651TI, Lot #s: 472560A, 472560B, 472570A, 518520A, 518520B, 472570B.
- 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.