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U.S. Department of Health and Human Services

Class 2 Device Recall StaXx IB Convex Expandable Implant

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  Class 2 Device Recall StaXx IB Convex Expandable Implant see related information
Date Initiated by Firm May 14, 2013
Date Posted September 11, 2013
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = SPINE WAVE, INC.
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