Z-2187-2013 Class II Terminated
FDA device recall Z-2187-2013 was initiated by Spine Wave, Inc. on May 14, 2013 and is designated Class II. Reason for recall: A component Superior endplate manufactured from a different polymer than specified The recall status is terminated (terminated February 10, 2014). Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2013
- Initiation Date
- May 14, 2013
- Termination Date
- February 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
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.
Reason for Recall
A component Superior endplate manufactured from a different polymer than specified
Distribution Pattern
Distributed in the states of FL and OR.
Code Information
Lot Numbers: 272L08 and 272L09