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U.S. Department of Health and Human Services

Class 2 Device Recall Calix T PEEK Lumbar System

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 Class 2 Device Recall Calix T PEEK Lumbar Systemsee related information
Date Initiated by FirmMay 17, 2016
Create DateOctober 18, 2016
Recall Status1 Terminated 3 on April 04, 2019
Recall NumberZ-0126-2017
Recall Event ID 74397
510(K)NumberK131350 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductCalix T PEEK Lumbar System, TLIF Rasp
Code Information Size, 28mm x 10mm x 6mm, Part #:, X034-0360, Lot #:, 23515, 23516, 24295, 24836, 24836s1, 24836S2, 657001, 760913 & Size, 28mm x 10mm x 10mm, Part #:, X034-0364, Lot #:, 23517, 23518, 24296, 24837, 657002, 760914.
FEI Number 3005031160
Recalling Firm/
Manufacturer		 X Spine Systems Inc
452 Alexandersville Rd
Miamisburg OH 45342-3658
For Additional Information ContactJessica Lalich
800-903-0640 Ext. 2143
Manufacturer Reason
for Recall		The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.
FDA Determined
Cause 2		Component design/selection
ActionConsignees will be notified via email and courier and will be instructed to return the affected product. Upon receipt of the recalled trays, the trials and rasps will be removed from the tray and quarantined for evenutal destruction.
Quantity in Commerce195 units
DistributionProduct was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MAX
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