Z-0127-2017Class II

Calix T PEEK Lumbar System, TLIF Trial

Name: Z-0127-2017 Calix T PEEK Lumbar System, TLIF Trial
Creator: X Spine Systems Inc
Published: 2016-05-17
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2016-05-17 / Terminated / root cause: design

FDA source

X Spine Systems Inc began a recall of Calix T PEEK Lumbar System, TLIF Trial on 2016-05-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0127-2017
Classification: Class II
Status: Terminated
Initiated: 2016-05-17
Posted: 2016-10-18
Terminated: 2019-04-04
Recalling firm: Xtant Medical Holdings, Inc.
Product: Calix T PEEK Lumbar System, TLIF Trial
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0127-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0124-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0125-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0126-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18
Z-0127-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18

Product code MAX

K131350Class IICalix Lumbar Spinal Implant SystemX-Spine Systems, Inc. / cleared 2013-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)