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 23541–23560 of 38,428 recalls
Recalled Item: PALLAS M/MAXIMIS Ratchet T Handle. 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 Dilator A. 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 35mm Rod. 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 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 30mm Rod. 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 Rod Pusher B. 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 80mm 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 Polyaxial and MIS 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 80mm 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 60mm Curved and Precontoured Rod. 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 50mm Curved 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 7.5 x 45mm. 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 70mm Curved 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 Extension Guide Bush. 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 Tapper 5.5mm. 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 40mm 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 5.5 x 40mm. 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 Rod Gauge. 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 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.