FDAFDA · Food and drugs·Recall number Z-2306-2020
A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Published June 17, 2020 · Recall initiated: May 14, 2020
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
Distributed to the field without having completed design history files or design transfer activities
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet
- Distributor
- Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
- Lot
- Lot Number: 3286A (01)00887868135033(10)3286A
- 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.