FDAFDA · Food and drugs·Recall number Z-1482-2013
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
Published June 12, 2013 · Recall initiated: May 10, 2008
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
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
- Lot
- Lot number: 20856
- 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.