Z-2187-2013 Class II Terminated

Recalled by Spine Wave, Inc. — Shelton, CT

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