Warsaw Orthopedic Inc.
FDA adverse event reports naming Warsaw Orthopedic Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: WARSAW ORTHOPEDIC INC..
- Total reports
- 1,741
- Deaths
- 12
- Injuries
- 947
- Malfunctions
- 750
Reports per year
Source: FDA adverse event reports by year received, 2001–2010. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Appliance, Fixation, Spinal InterlaminalKWP671
- Appliance, Fixation, Spinal Intervertebral BodyKWQ296
- Orthopedic Manual Surgical InstrumentLXH142
- Screw, Fixation, BoneHWC129
- Posterior Metal/Polymer Spinal System, FusionNQP126
- ScrewdriverHXX46
- Prosthesis, Intervertebral DiscMJO34
- Thoracolumbosacral Pedicle Screw SystemNKB33
- Plate, Fixation, BoneHRS28
- Intervertebral Fusion Device With Bone Graft, LumbarMAX28
Recent recalls
- 2009-03-12TerminatedProcess control
Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
- 2009-03-12TerminatedProcess control
Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; Medtronic Sofamor Danek, Memphis, TN; REF 8351510. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
- 2009-03-12TerminatedProcess control
Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF 8351511. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
- 2009-03-12TerminatedProcess control
Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
- 2008-02-07TerminatedProcess control
Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.
- 2007-11-07TerminatedPackage design/selection
Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.
Packaging weakness may compromise sterility and instructions for use are inadequate.
- 2005-08-06TerminatedOther
Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423.
The product is labeled as sterile, but this lot was not sterilized.
- 2005-07-13TerminatedPackage design/selection
Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
- 2005-07-13TerminatedPackage design/selection
Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
- 2005-07-13TerminatedPackage design/selection
Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
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