Recall Register

Food, drugs, devices › Firms

RTI Surgical, Inc.

FDA recalling firm · 3 enforcement events · 3 product records · 2013–2017 · FL, MI

RTI Surgical, Inc. has 3 FDA enforcement events on this register (3 product records) between 2013 and 2017: 3 device; the busiest year was 2013 with 2.

0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in FL and MI.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
23 Jan 2017RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applicationsDeviceClass II1Terminated
6 Dec 2013***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.DeviceClass II1Terminated
7 Oct 2013C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and…DeviceClass II1Terminated

By type and class

Device3
Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for RTI Surgical, Inc. by year initiated.

Questions and answers

How many FDA recalls has RTI Surgical, Inc. had?

3 enforcement events (3 product records) on this register, 2013–2017: 3 device.

Are any RTI Surgical, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are RTI Surgical, Inc. recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.