Z-2335-2021 Class II Terminated
FDA device recall Z-2335-2021 was initiated by BioMimetic Therapeutics, LLC on Jul 23, 2021 and is designated Class II. Reason for recall: The kit contains the wrong vial tray in the package. The recall status is terminated (terminated Sep 4, 2024). Affected quantity: 499 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 1, 2021
- Initiation Date
- Jul 23, 2021
- Termination Date
- Sep 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 499 units
Product Description
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Reason for Recall
The kit contains the wrong vial tray in the package.
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.
Code Information
Model Number K30003010, Lot 1706343
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2335-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026