RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Hazard
Incorrect instructions for use (IFU) included.
What You Should Do
Remedy
The firm, RTI Surgical, Inc., issued and "IMPORTANT NOTIFICATION Field Action" letter dated January 20th, 2017 to its consignee via e-mail on 01/23/2017. Verification and confirmation of the e-mail was received on the same date. The letter described the product, problem and actions to be taken. The consignee were instructed to immediately quarantine any grafts in your possession; return any unused RTI and include return authorization along with instructions on how to return the product. If you have any questions, Sr. Manager, Regulatory Compliance at 386-418-8888 ext. 4396 or email: amcconnell@rtix.com.
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Products
RTI Biologics BioSet IC RT Paste 2 cc
Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
- Brand
- RTI Surgical, Inc.
- UPC
- Serial #'s: 30303308, 30303321, 30303327, 30303340, 3034313, 30304314, 30304330, 30401686, 30401699, 30401714, 30401721, 30401723, 30401730, 30401732, 30401735, 3041741, 30401746, 30401750, 30718244, 30718441, 30718442, 30718448, and 30718449.
Units Affected
24 units