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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 499
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
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