Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0429-2021 — 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

U.S. FDA — Device Enforcement · United States · 2020-09-30 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0429-2021
Date of alert
2020-09-30
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
XTANT Medical
Product category
device
Product type
Devices
Reported risk: Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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