The Recall Desk

Manufacturer

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

50 recalls in our database name RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) as the manufacturing or recalling firm.

What the numbers show

Total
50
Critical
0
Severe
43
Most recent
2021-03-17

Of the 50 recalls from RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 43 (86%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 50

  • SevereFDA (Devices)·Z-1231-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recall for Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1216-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1232-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate during or after surgery, requiring revision.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1224-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1238-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1211-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1226-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1236-2021·2021-03-17

    Pioneer Surgical Technology Recalls CervAlign Anterior Cervical Plate System

    RTI Surgical, Inc. is recalling the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - 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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1209-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1239-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1208-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1228-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recall for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1219-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1204-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling 65 units of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1215-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - 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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1222-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2021·2020-11-11

    RTI Surgical Recalls Streamline MIS Navigation System Taps

    RTI Surgical is recalling 143 units of Streamline MIS Navigation System Taps because they are not compatible with the Streamline MIS tap sleeve.

    Product
    Streamline 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-MDN
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0322-2021·2020-11-11

    RTI Surgical Recalls Streamline OCT Navigated Instruments Due to Missing Drill Guide

    RTI Surgical is recalling 76 units of Streamline OCT Navigated Instruments because the system does not include a drill guide. The devices were distributed to one distributor in Michigan.

    Product
    Streamline 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.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0299-2021·2020-11-04

    RTI Surgical Recalls Streamline MIS Navigation System Taps Due to Binding

    RTI Surgical is recalling 420 units of Streamline MIS Navigation System Taps because they have experienced binding with other devices.

    Product
    Streamline 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: i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0300-2021·2020-11-04

    RTI Surgical Recalls Streamline TL Navigation System Taps Due to Binding

    RTI Surgical is recalling 420 units of Streamline TL Navigation System taps because they have experienced binding with other devices.

    Product
    Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-INSERTER-MDN 02-SCREWINS-CL-MDN 02-SCREWINS-C-MDN 02-S-FIN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0290-2017·2016-10-26

    RTI Surgical Recalls Streamline OCT Spinal Rods Due to Cracks

    RTI Surgical is voluntarily recalling 66 units of Streamline OCT spinal rods due to potential cracks that could reduce strength and cause patient injury.

    Product
    RTI 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 intend
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2016·2016-06-01

    RTI Surgical Recalls Streamline OCT Spinal Fixation Instruments

    RTI Surgical is recalling 17 Streamline OCT Crosslink Counter Torque Sleeves because a defect may obstruct the cannula, potentially causing driver slippage and patient injury.

    Product
    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1393-2016·2016-04-20

    RTI Surgical Streamline OCT Final Driver Recalled for Fracture Risk

    RTI Surgical is recalling Streamline OCT Final Drivers due to reduced mechanical strength that may cause the tip to fracture during use.

    Product
    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2053-2015·2015-07-15

    RTI Surgical Recalls Songer Spinal Cable System Due to Labeling Error

    RTI Surgical is recalling 25 units of the Songer Spinal Cable System because the box end label incorrectly identifies the material as Titanium instead of Stainless Steel.

    Product
    Songer 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.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1916-2015·2015-07-08

    RTI Surgical Recalls Mislabeled Bullet-Tip PEEK VBR Implants

    RTI Surgical is recalling 18 units of three lots of Bullet-Tip PEEK VBR implants distributed in Florida and New York due to incorrect color labeling.

    Product
    Bullet-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,
    Category
    Medical Device
    Distribution
    2 states