FDAFDA · Food and drugs·Recall number Z-1607-2024
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
Published May 1, 2024 · Recall initiated: March 13, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
- Lot
- Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530;
- 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.