RTI Biologics BioSet IC RT Paste 2 cc Filler — Class II medical device recall Z-1441-2017
Terminated recall by RTI Surgical, Inc., reported 2017-03-22. Incorrect instructions for use (IFU) included.
| Recall number | Z-1441-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RTI Surgical, Inc., Alachua, FL, United States |
| Recall initiated | 2017-01-23 |
| Classified | 2017-03-10 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2018-04-05 |
| Countries outside the US | CO |
| Quantity | 24 units |
| Serial numbers | 30303308, 30303321, 30303327, 30303340, 30304314, 30304330, 3034313, 30401686, 30401699, 30401714, 30401721, 30401723, 30401730, 30401732, 30401735, 30401746, 30401750, 3041741, 30718244, 30718441, 30718442, 30718448, 30718449 |
Product
RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Reason for recall
Incorrect instructions for use (IFU) included.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1441-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.