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Terminated

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

FDA Recall Z-1441-2017 · Posted None

Recalling FirmRTI Surgical, Inc.
Recall StatusTerminated
Product CodeMQV
Date Initiated2017-01-23
Date Terminated2018-04-05
Product Quantity24 units

Reason for Recall

Incorrect instructions for use (IFU) included.

Firm 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].

Root Cause

Labeling Change Control

Distribution Pattern

International Distribution: Colombia only

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043421OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP ICRegeneration Technologies, Inc. · 2005-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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