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Open, Classified

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FDA Recall Z-1897-2026 · Posted 2026-04-21

Recall StatusOpen, Classified
Product CodeMQV
Date Initiated2026-03-09
Product Quantity225

Reason for Recall

Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

Firm Action

On March 9, 2026, the firm began notifying customers via letters titled "URGENT: MEDICAL DEVICE RECALL." Customers were instructed to segregate and quarantine all affected products to prevent use, and discontinue use of any affected product. Affected product must be returned to Xtant Medical.

Root Cause

Incorrect or no expiration date

Distribution Pattern

US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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