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U.S. Department of Health and Human Services

Class 2 Device Recall Calix P PEEK Lumbar System

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  Class 2 Device Recall Calix P PEEK Lumbar System see related information
Date Initiated by Firm May 17, 2016
Create Date October 18, 2016
Recall Status1 Terminated 3 on April 04, 2019
Recall Number Z-0124-2017
Recall Event ID 74397
510(K)Number K131350  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Calix P PEEK Lumbar System, PLIF Rasp
Code Information Size, 22mm x 10mm x 6mm, Part #:, X034-0990, Lot #:, 015641-2-1, 015641-2-1R, 015857-24-1, 020316, 020329, 020746, 19894, UP1009, UPI002, UPI005, UPI008 & Size, 22mm x 10mm x 10mm, Part #:, X034-0994, Lot #:, 015641-3-1, 015641-3-1R,015857-25-1, 020317, 020330, 020747, UPI001, UPI004, UPI007.
Recalling Firm/
Manufacturer		 X Spine Systems Inc
452 Alexandersville Rd
Miamisburg OH 45342-3658
For Additional Information Contact Jessica 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
Action Consignees 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 Commerce 182 units
Distribution Product 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 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 = X-SPINE SYSTEMS, INC
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