Class 2 Device Recall StaXx IB Convex Expandable Implant

• Date Initiated by Firm: May 14, 2013
• Date Posted: September 11, 2013
• Recall Status: Terminated on February 10, 2014
• Recall Number: Z-2187-2013
• Recall Event ID: 65968
• 510(K)Number: K123461
• Product Classification: Intervertebral fusion device with bone graft, lumbar - Product Code MAX
• 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.
• Code Information: Lot Numbers: 272L08 and 272L09
• FEI Number: 3004638600
• Recalling Firm/ Manufacturer: Spine Wave, Inc.; 3 Enterprise Dr Ste 302; Shelton CT 06484-4694
• For Additional Information Contact: 203-944-9494
• Manufacturer Reason for Recall: A component Superior endplate manufactured from a different polymer than specified
• FDA Determined Cause: Component change control
• Action: Spine Wave notified surgeons verbally on 5/14/13 and followed by written notification on June 6, 2013 of the incorrect polymer used for the endplate and the health risks.
• Quantity in Commerce: 17 units
• Distribution: Distributed in the states of FL and OR.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MAX