Z-0429-2021Class III

XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the...

Name: Z-0429-2021 XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the...
Creator: XTANT Medical
Published: 2020-09-30
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2020-09-30 / Terminated / root cause: labeling and UDI

FDA source

XTANT Medical began a recall of XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI... on 2020-09-30. FDA classified it as Class III and gives the reason as "Cervical Implants contain a label that incorrectly identifies the grade of titanium used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0429-2021
Classification: Class III
Status: Terminated
Initiated: 2020-09-30
Posted: 2020-11-06
Terminated: 2021-05-21
Recalling firm: Xtant Medical Holdings, Inc.
Product: XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4, Ref: X098-0108-STR DI Number: M697X0980108STR1 Mat.: CP Ti Grade 5, Ref: X098-0109-STR DI Number: M697X0980109STR1 Mat.: CP Ti Grade 6, Ref: X098-0110-STR DI Number: M697X0980110STR1 Mat.: CP Ti Grade 7, Ref: X098-0111-STR DI Number: M697X0980111STR1 Mat.: CP Ti Grade 8, Ref: X098-0112-STR DI Number: M697X0980112STR1 Mat.: CP Ti Grade 9, Ref: X098-0205-STR DI Number: M697X0980205STR1 Mat.: CP Ti Grade 10, Ref: X098-0206-STR DI Number: M697X0980206STR1 Mat.: CP Ti Grade 11, Ref: X098-0207-STR DI Number: M697X0980207STR1 Mat.: CP Ti Grade 12, Ref: X098-0208-STR DI Number: M697X0980208STR1 Mat.: CP Ti Grade 13, Ref: X098-0209-STR DI Number: M697X0980209STR1 Mat.: CP Ti Grade 14, Ref: X098-0210-STR DI Number: M697X0980210STR1 Mat.: CP Ti Grade 15, Ref: X098-0211-STR DI Number: M697X0980211STR1 Mat.: CP Ti Grade 16, Ref: X098-0212-STR DI Number: M697X0980212STR1 Mat.: CP Ti Grade 17, Ref: X098-0305-STR DI Number: M697X0980305STR1 Mat.: CP Ti Grade 18, Ref: X098-0306-STR DI Number: M697X0980306STR1 Mat.: CP Ti Grade 19, Ref: X098-0307-STR DI Number: M697X0980307STR1 Mat.: CP Ti Grade 20, Ref: X098-0308-STR DI Number: M697X0980308STR1 Mat.: CP Ti Grade 21, Ref: X098-0309-STR DI Number: M697X0980309STR1 Mat.: CP Ti Grade 22, Ref: X098-0310-STR DI Number: M697X0980310STR1 Mat.: CP Ti Grade 23, Ref: X098-0311-STR DI Number: M697X0980311STR1 Mat.: CP Ti Grade 24, Ref: X098-0312-STR DI Number: M697X0980312STR1 Mat.: CP Ti Grade 25
Product code: ODP Intervertebral Fusion Device With Bone Graft, Cervical
Reason for recall: Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 9/30/2020 and 10/29/2020, a "Urgent: Medical Device Recall" notification was sent to consignees via FedEx Priority Overnight. In addition to notifying the consignee about the labeling issue, the recall notification as consignees to take the following actions: 1. Immediately examine your inventory and quarantine any affected products subject to this recall. See enclosed illustration for ease in identifying affected products (see Attachment 2). 2. Please complete the enclosed Acknowledgement Form (Attachment 1), even if you have no remaining devices in your inventory, and return the completed Acknowledgment Form to the Attention of Michele Dolan via: Mail: Xtant Medical InTice-C Porous Ti Cervical Interbody System Recall 664 Cruiser Lane Belgrade, MT 59714 Email: [email protected] Fax:1-406-388-3380 3. Return Affected Product Contact Michele Dolan at [email protected], or 1-406-388-0480 ext. 1127, between 8 a.m. and 5 p.m. (Mountain Time) to obtain instructions for returning affected product, and to obtain replacement devices which will be provided at no cost to you. 4. Package the affected products to be returned. Xtant will provide a shipping container (if needed) with a return shipping label. Securely package the affected product(s). Send the container at your earliest opportunity to: ATTN: InTice-C Porous Ti Cervical Interbody System Recall RA# 20-xxxx Xtant Medical 732 Cruiser Lane Belgrade, MT 59714 If you have any questions, please contact Rebecca Lennemann, Director of RAQA, 1-406-388-0480 ext. 1125, from 8 a.m. to 5 p.m. (Mountain Time). For consignees that have already implanted the device: 1. The product does not pose any health risk. The product is correctly manufactured with commercially pure Titanium (CP-Ti), Grade 2, and as such, there is no need for surgical intervention. 2. This notice is being provided only as a notification of the recall and requires completion of the Customer Acknowl
Quantity in commerce: 508 units
Distribution: US: FL, TX, CA, OH, AZ, OH OUS: None
Product codes and lots: Reference Number/Lot Number/Expiration date: X098-0106-STR/ 1220190000207152/ 12-13-24, X098-0107-STR / 1220190000207153/ 12-06-24, X098-0108-STR / 1220190000207154/ 12-06-24, X098-0109-STR / 0120200000207155 / 01-10-25, X098-0110-STR / 0120200000207156 / 01-10-25, X098-0111-STR / 0120200000207157 / 01-10-25, X098-0112-STR / 1220190000207158 / 12-07-24, X098-0205-STR / 1220190000207159 / 12-06-24, X098-0206-STR / 12201900002071510 / 12-06-24, X098-0207-STR / 12201900002071511 / 12-07-24, X098-0208-STR / 12201900002071512 / 12-07-24, X098-0209-STR / 12201900002071513 / 12-06-24, X098-0210-STR / 12201900002071514 / 12-07-24, X098-0211-STR / 12201900002071515 / 12-07-24, X098-0212-STR / 12201900002071516 / 12-07-24, X098-0305-STR / 02202000002071517 / 02-05-25 X098-0306-STR / 12201900002071518 / 12/13/24, X098-0307-STR / 01202000002071519 / 01-10-25, X098-0308-STR / 12201900002071520 / 1213-24, X098-0309-STR / 12201900002071521 / 12-07-24, X098-0310-STR / 12201900002071522 / 12-07-24, X098-0311-STR / 12201900002071523 / / 12-07-24, X098-0312-STR / 12201900002071524 / 12-08/24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0429-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0429-2021	Class III	Terminated	Voluntary: Firm initiated	2020-11-18	2020-11-06

Product code ODP

K173832Class IIInTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. / cleared 2018-05-17

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)