Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 23601–23620 of 38,428 recalls
Recalled Item: PALLAS M/MAXIMIS Anti Torque Device. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS MIS Alignment Driver. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. Part of MAXIMIS Pedicle
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm and 6.5 x
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Extension Block. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Set Screw. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 50mm Straight Rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 35mm MIS rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 500mm Straight Rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 70mm Straight Rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 120mm MIS Rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Compass. Part of MAXIMIS Pedicle Screw Spinal Fixation
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS 45mm MIS Rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Head Holder. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.