FDA Medical Device Recalls (openFDA)
RTI Surgical, Inc.: RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
- Recall number
- Z-1441-2017
- Recalling firm
- RTI Surgical, Inc.
- Product
- RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
- Status
- Terminated
- Initiated
- 2017-01-23
- Posted
- not on file
- Terminated
- 2018-04-05
- Reason
- Incorrect instructions for use (IFU) included.
- Root cause
- Labeling Change Control
- Action
- 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.
- Quantity
- 24 units
- Distribution
- International Distribution: Colombia only
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K043421"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3002719998
- Firm city
- Alachua
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28