Recall Z-2187-2013— Spine Wave, Inc.

Name: FDA recall Z-2187-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-14

Class II · Terminated

Class II FDA medical device recall by Spine Wave, Inc., initiated 2013-05-14, terminated 2014-02-10. It names one FDA 510(k) clearance: K123461. Product: 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: A component Superior endplate manufactured from a different polymer than specified.

Recalling firm: Spine Wave, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-14
Terminated: 2014-02-10
Firm location: Shelton, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K123461 — STAXX(R) IB SYSTEMSpine Wave, Inc.·cleared 2013-04-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.