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.

38,428 total recalls
0 this month

Showing 23621–23640 of 38,428 recalls

June 21, 2017· Valorem Surgical LLC

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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Nut Driver 4.0 Hexa and Alignment Driver. Part

The Issue: Devices are not consistent with Quality System Requirements

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Large Crosslink. 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS MIS Anti Torque. 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Extension Driver. 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Poly Screw 5.5 x 55mm. Part of MAXIMIS

The Issue: Devices are not consistent with Quality System Requirements

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS 40mm 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Poly Screw 5.5 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Extension Sleeve. 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Persuader. 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Tapper 6.5. 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS 45mm 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Poly Screw 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS 45mm MIS . 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS MIS Screw 7.5 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS Set Screw Starter. 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS MIS Screw 6.5 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS MISS/MIS Poly Screw Driver. 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.

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS MIS Screw 6.5 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.

Class II — Potential Health HazardTerminated