FDAFDA · Food and drugs·Recall number Z-2187-2013
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
Published September 18, 2013 · Recall initiated: May 14, 2013
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
A component Superior endplate manufactured from a different polymer than specified
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Spine Wave, Inc.
- Distributor
- Distributed in the states of FL and OR.
- Lot
- Lot Numbers: 272L08 and 272L09
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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