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RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Recalls
50 recalls on record · July 8, 2015 to March 17, 2021 · Medical Devices
Recalls by year
15
16
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21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for a
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for a
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for a
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for a
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage: intended for a
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - Product Usage: intended for
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage: intended for
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
March 17, 2021Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for
Hazard: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
November 11, 2020Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-F
Hazard: System does not include a drill guide.
November 11, 2020Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CA
Hazard: The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
November 4, 2020Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls 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
Hazard: The Streamline Navigation System taps have experienced binding with other devices.
November 4, 2020Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNT
Hazard: The Streamline Navigation System taps have experienced binding with other devices.
October 26, 2016Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When in
Hazard: 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 strength of these affected implants, and lead to patient injury.
June 1, 2016Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
Hazard: 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.
April 20, 2016Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Hazard: Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.
July 15, 2015Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be u
Hazard: 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.
July 8, 2015Medical DevicesFDA
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEE
Hazard: 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.