Z-1441-2017Class II

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

Name: Z-1441-2017 RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and...
Creator: RTI Surgical, Inc.
Published: 2017-01-23
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2017-01-23 / Terminated / root cause: labeling and UDI

FDA source

RTI Surgical, Inc. began a recall of RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications on 2017-01-23. FDA classified it as Class II and gives the reason as "Incorrect instructions for use (IFU) included". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1441-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-23
Posted: 2017-03-10
Terminated: 2018-04-05
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Incorrect instructions for use (IFU) included.
Root cause tag: labeling and UDI
FDA 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: [email protected].
Quantity in commerce: 24 units
Distribution: International Distribution: Colombia only
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1441-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1441-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-10

Product code MQV

K043421Class IIOpteform, Osteofil, Rti Allograft Paste Ic, Rti Allograft Strip IcRegeneration Technologies, Inc. / cleared 2005-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)