Spine Wave, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2187-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 14, 2013

Date Posted: September 18, 2013

Recall Number: Z-2187-2013

Event ID: 65968

Reason for Recall:

A component Superior endplate manufactured from a different polymer than specified

Status: Terminated

Product Quantity: 17 units

Code Information:

Lot Numbers: 272L08 and 272L09

Distribution Pattern:

Distributed in the states of FL and OR.

Voluntary or Mandated:

Voluntary: Firm initiated