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Terminated

AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343

FDA Recall Z-2335-2021 · Posted None

Recalling FirmBioMimetic Therapeutics, LLC
Recall StatusTerminated
Product CodeNOX
Date Initiated2021-07-23
Date Terminated2024-09-04
Product Quantity499 units

Reason for Recall

The kit contains the wrong vial tray in the package.

Firm Action

Recall communication was sent out via FedEx Priority Overnight. Customers are instructed to immediately quarantine all recalled products they have and return all affected product to the recalling firm's Arlington, TN Warehouse as soon as possible. If they have further distributed the affected product, they are instructed to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and the recalling firm will work directly with them to collect the recalled items.

Root Cause

Packaging process control

Distribution Pattern

US Nationwide distribution in the states of AK, CA, CO, FL, GA, IA, ID, IL, IN, MA, MI, MN, NC, NJ, NM, NY, OH, OR, PA, TX, UT, VA, WA, and WI.

Official Source

View FDA Recall →

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

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