FDA Device recall Z-1441-2017
RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound by Rti Surgical, citing incorrect instructions for use (IFU) included.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1441-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-23 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Rti Surgical |
| Distribution | n/a |
Product
RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Reason
Incorrect instructions for use (IFU) included.
Identifiers
| code_info | Serial #'s: 30303308, 30303321, 30303327, 30303340, 3034313, 30304314, 30304330, 30401686, 30401699, 30401714, 30401721…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1441-2017%22
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