|
Class 2 Device Recall Calix T PEEK Lumbar System |
|
Date Initiated by Firm |
May 17, 2016 |
Create Date |
October 18, 2016 |
Recall Status1 |
Terminated 3 on April 04, 2019 |
Recall Number |
Z-0127-2017 |
Recall Event ID |
74397 |
510(K)Number |
K131350
|
Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
|
Product |
Calix T PEEK Lumbar System, TLIF Trial |
Code Information |
Size, 28mm x 10mm x 6mm, Part #:, X034-0340, Lot #:, 118501, 23502, 23503, 24284, 24291, 24825, 24825s1, 24825S2, 760902; Size, 28mm x 10mm x 7mm, Part #:, X034-0341, Lot #:, 118502, 23504, 24285, 24826, 24826S1, 24826S2, 760903; Size, 28mm x 10mm x 8mm, Part #:, X034-0342, Lot #:, 118503, 23505, 24286, 24827, 24827S1, 24827S2, 760904; Size, 28mm x 10mm x 9mm, Part #:, X034-0343, Lot #:, 118504, 23506, 24287, 24828, 24828S1, 24828S2, 760905; Size, 28mm x 10mm x 10mm, Part #:, X034-0344, Lot #:, 118505, 23507, 24288, 24829, 24829S1, 24829S2, 760906; Size, 28mm x 10mm x 11mm, Part #:, X034-0345, Lot #:, 118506, 23508, 24289, 24830, 24830S1, 24830S2, 760907; Size, 28mm x 10mm x 12mm, Part #:, X034-0346, Lot #:, 118507, 23509, 24290, 24831, 24831S1, 24831s2, 760908; Size, 28mm x 10mm x 13mm, Part #:, X034-0347, Lot #:, 118508, 23510, 24291, 24832, 24832s1, 24832S2, 760909; Size, 28mm x 10mm x 14mm, Part #:, X034-0348, Lot #:, 118509, 23511, 24292, 24833, 760910; Size, 28mm x 10mm x 15mm, Part #:, X034-0349, Lot #:, 118510, 23512, 24293, 24293-R, 24834, 760911 & Size, 28mm x 10mm x 16mm, Part #:, X034-0350, Lot #:, 118511, 23513, 23514, 24294, 24835, 24835S1, 24835S2, 32513, 760912. |
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 |
1186 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
|
|
|
|