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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 Recall
StaXx IB Convex Expandable Implant
see related information
Date Posted September 11, 2013
Recall Status1 Terminated on February 10, 2014
Recall Number Z-2187-2013
Recall Event ID 65968
Premarket Notification
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, Connecticut 06484-4694
Manufacturer Reason
for Recall
A component Superior endplate manufactured from a different polymer than specified
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = SPINE WAVE, INC.
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