Device product

RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications

Z-1441-2017

January 23, 2017

Class II

Product summary

Firm: RTI Surgical, Inc.
Event: Event 76473
Status: Terminated
Classification: Class II
Quantity: 24 units
Official record key: device-enforcement:Z-1441-2017

Official wording

Reason: Incorrect instructions for use (IFU) included.

Code information: 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.

Distribution pattern: International Distribution: Colombia only

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Incorrect instructions for use (IFU) included.