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Recall Observatory FDA recall evidence

Device product

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

Z-2335-2021

July 23, 2021

Class II

Product summary

Firm
BioMimetic Therapeutics, LLC
Event
Event 88395
Status
Terminated
Classification
Class II
Quantity
499 units
Official record key
device-enforcement:Z-2335-2021

Official wording

Reason: The kit contains the wrong vial tray in the package.

Code information: Model Number K30003010, Lot 1706343

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The kit contains the wrong vial tray in the package.