The Recall Desk
HighFDA (Devices)·Z-2335-2021·Announced 2021-09-01

AUGMENT Injectable Kit Recalled for Wrong Vial Tray in Package

BioMimetic Therapeutics is recalling AUGMENT Injectable Kits (Model K30003010, Lot 1706343) because some packages contain the wrong vial tray. The recall affects 499 units distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Classified as High because the wrong vial tray in an injectable kit represents a risk-of-harm product that could affect proper administration and patient safety, despite no injuries or illnesses being reported to date.

Plain-English summary

BioMimetic Therapeutics, LLC is recalling AUGMENT Injectable Kit, 3cc (Model K30003010, Lot 1706343). The kit contains the wrong vial tray in the package.

A total of 499 units were distributed nationwide in 23 states: Alaska, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington, and Wisconsin.

Patients and healthcare providers who have received this product should contact BioMimetic Therapeutics, LLC for return or replacement instructions.

The recalled product

Product
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Manufacturer
BioMimetic Therapeutics, LLC
Category
Medical Device — Injectable
Hazard
  • packaging-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model Number K30003010
  • Lot 1706343

Distribution

Distributed nationwide across the United States.

Related recalls

Same category