Recall Register

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RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA recalling firm · 9 enforcement events · 50 product records · 2015–2021 · MI

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) has 9 FDA enforcement events on this register (50 product records) between 2015 and 2021: 9 device; the busiest year was 2016 with 3.

0% of its events are Class I; the most common class is Class II (9). 2 events are listed as ongoing; the recalling firm's address is in 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
15 Jan 2021CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and…DeviceClass II41Ongoing
24 Sep 2020Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN Product Usage: intended to be used during the preparation and…DeviceClass II2Terminated
24 Sep 2020Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.DeviceClass II1Ongoing
11 Sep 2020Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDNDeviceClass II1Terminated
16 Sep 2016RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as…DeviceClass II1Terminated
22 Apr 2016Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.DeviceClass II1Terminated
18 Mar 2016RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw DriverDeviceClass II1Terminated
29 May 2015Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.DeviceClass II1Terminated
21 May 2015Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant,…DeviceClass II1Terminated

By type and class

Device9
Class II9

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

Events by year

15
16
17
18
19
20
21
22
23
24
25
26
Enforcement events for RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) by year initiated.

Questions and answers

How many FDA recalls has RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) had?

9 enforcement events (50 product records) on this register, 2015–2021: 9 device.

Are any RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls ongoing?

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

What class are RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls?

9 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.