Events

Recall of Device Recall OPTEFORM Allograft Paste

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RTI Surgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67246
  • Event Risk Class
    Class 2
  • Event Number
    Z-0939-2014
  • Event Initiated Date
    2013-12-06
  • Event Date Posted
    2014-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125083
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Filler, bone void, calcium compound - Product Code MQV
  • Reason
    Rti surgical, inc. of alachua, fl is recalling their opteform allograft paste, 5cc as it may contain a 10 cc fluid dispenser. the 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.
  • Action
    RTI Surgical issued a: URGENT: Medical Device Recall Notification dated December 6, 2013 to their customer. The customer was instructed to quarantine the product immediately and return to RTI Surgical, Inc. for final disposition. For questions or concerns, call 386-418-8888.

Device

Device Recall OPTEFORM Allograft Paste
  • Model / Serial
    Serial Numbers: 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458 and 8504459.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to Florida.
  • Product Description
    ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.
  • Manufacturer
    RTI Surgical, Inc.

Manufacturer

RTI Surgical, Inc.
  • Manufacturer Address
    RTI Surgical, Inc., 11621 Research Cir, Alachua FL 32615-6825
  • Manufacturer Parent Company (2017)
    RTI Surgical Inc
  • Source
    USFDA