XTANT Medical — Class III medical device recall Z-0429-2021
Terminated recall by XTANT Medical, reported 2020-11-18, distributed in AZ, CA, FL, OH, TX. Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
| Recall number | Z-0429-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | XTANT Medical, Belgrade, MT, United States |
| Recall initiated | 2020-09-30 |
| Classified | 2020-11-06 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2021-05-21 |
| Distributed | AZ, CA, FL, OH, TX |
| Quantity | 508 units |
| Reason classes | labeling |
| Lot numbers | 01202000002071519, 0120200000207155, 0120200000207156, 0120200000207157, 02202000002071517, 1213-24, 12201900002071510, 12201900002071511, 12201900002071512, 12201900002071513, 12201900002071514, 12201900002071515, 12201900002071516, 12201900002071518, 1220190000207152, 12201900002071520, 12201900002071521, 12201900002071522, 12201900002071523, 12201900002071524, 1220190000207153, 1220190000207154, 1220190000207158, 1220190000207159, X098-0106-STR, X098-0107-STR, X098-0108-STR, X098-0109-STR, X098-0110-STR, X098-0111-STR, X098-0112-STR, X098-0205-STR, X098-0206-STR, X098-0207-STR, X098-0208-STR, X098-0209-STR, X098-0210-STR, X098-0211-STR, X098-0212-STR, X098-0305-STR and 7 more |
| Model numbers | M697X0980106STR1, M697X0980107STR1, M697X0980108STR1, M697X0980109STR1, M697X0980110STR1, M697X0980111STR1, M697X0980112STR1, M697X0980205STR1, M697X0980206STR1, M697X0980207STR1, M697X0980208STR1, M697X0980209STR1, M697X0980210STR1, M697X0980211STR1, M697X0980212STR1, M697X0980305STR1, M697X0980306STR1, M697X0980307STR1, M697X0980308STR1, M697X0980309STR1, M697X0980310STR1, M697X0980311STR1, M697X0980312STR1, X098-0106-STRDI, X098-0107-STRDI and 21 more |
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
Reason for recall
Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0429-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.