# FDA recall Z-0429-2021

> **XTANT Medical** · Class III · device recall initiated 2020-09-30.

## 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 N

## Reason for recall

Cervical Implants contain a label that incorrectly identifies the grade of titanium used.

## Distribution

US: FL, TX, CA, OH, AZ, OH  OUS: None

## Key facts

- **Recall number:** Z-0429-2021
- **Recalling firm:** XTANT Medical
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-30
- **Report date:** 2020-11-18
- **Termination date:** 2021-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Belgrade, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0429-2021

## Citation

> AI Analytics. FDA recall Z-0429-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0429-2021. Source: US FDA. Licensed CC0.

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