OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Reported: June 10, 2020 Initiated: April 2, 2020 #Z-2181-2020
Product Description
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Reason for Recall
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Details
- Recalling Firm
- Osteomed, LLC
- Units Affected
- 270
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA. MA, MD, ME. MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of AUSTRALIA, ITALY, KOREA, MALAYSIA, PERU, SINGAPORE and THAILAND.
- Location
- Addison, TX
Frequently Asked Questions
What product was recalled? ▼
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.. Recalled by Osteomed, LLC. Units affected: 270.
Why was this product recalled? ▼
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2181-2020.
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