Recall archive
8 recalls · page 1 of 1
Reported Mar 17, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Matched: Brand — Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
40 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 11, 2020
Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Matched: Brand — The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 4, 2020
Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Matched: Brand — The Streamline Navigation System taps have experienced binding with other devices.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2016
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Matched: Brand · Product · Product details · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Jun 1, 2016
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Matched: Brand — Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the…
FDA (openFDA device enforcement)
Reported Apr 20, 2016
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Matched: Brand · Product · Product details — Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.
FDA (openFDA device enforcement)
Reported Jul 15, 2015
Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Matched: Brand — The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable,…
FDA (openFDA device enforcement)
Reported Jul 8, 2015
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Matched: Brand — 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…
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up