FDA Device recall Z-0127-2017
Calix T PEEK Lumbar System, TLIF Trial
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Calix T PEEK Lumbar System, TLIF Trial by X Spine Systems, citing 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 spa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0127-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-17 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | X Spine Systems |
| Distribution | AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX, WV |
Product
Calix T PEEK Lumbar System, TLIF Trial
Reason
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.
Identifiers
| code_info | Size, 28mm x 10mm x 6mm, Part #:, X034-0340, Lot #:, 118501, 23502, 23503, 24284, 24291, 24825, 24825s1, 24825S2, 76090…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0127-2017%22
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