RTI Surgical, Inc. (dba RTI Biologics, Inc.)

Activity by year

Devices registered here (1)

• Brace, Drill
  Product code HXY (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

Recalls & enforcement

• Class IIOngoing2021-01-15
  Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
• Class IIOngoing2020-09-24
  System does not include a drill guide.
• Class IITerminated2020-09-24
  The Streamline Navigation System taps have experienced binding with other devices.
• Class IITerminated2020-09-11
  The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
• Class IITerminated2017-01-23
  Incorrect instructions for use (IFU) included.
• Class IITerminated2016-09-16
  RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline® OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods. The small cracks on the rods used in implants could cause reduced stre…
• Class IITerminated2016-04-22
  Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.
• Class IITerminated2016-03-18
  Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.
• Class IITerminated2015-05-29
  The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile, distributed by DePuy Spine Inc.
• Class IITerminated2015-05-21
  Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial.
• Class IITerminated2013-12-06
  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.
• Class IITerminated2013-10-07
  As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this de…

FDA inspections (1)

• NAI2016-06-10
  No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

• All facilities operated by RTI Surgical, Inc. (dba RTI Biologics, Inc.)
• Tutogen Medical GmBH (DE)
• COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen (MN)

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)