Valorem Surgical LLC

Complete recall history across all FDA and CPSC categories — 144 total recalls

Valorem Surgical LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (144)

FDA medical device enforcement actions by Valorem Surgical LLC. Showing most recent 50.

Date Product Reason Class
Jun 21, 2017 PALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal Fixation S... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 250mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fix... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS S. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Rod Pusher Angled. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMI... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Reduction B. Part of MAXIMIS Pedicle Screw Spinal Fixation S... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 30 mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 mm screw. Part of MAXIMIS... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal ... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Crosslink 50-70mm. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5 mm screw. Part of MAXIMIS Ped... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pe... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 70mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS MISS/MIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Sp... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 40mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Set Screw Starter. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 7.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 45mm MIS . Part of MAXIMIS Pedicle Screw Spinal Fixation Sys... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 45mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixati... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Tapper 6.5. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Persuader. Part of MAXIMIS Pedicle Screw Spinal Fixation Sys... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Extension Sleeve. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 40mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS MIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixati... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Extension Driver. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Large Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixati... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Nut Driver 4.0 Hexa and Alignment Driver. Part of MAXIMIS Pe... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Head Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation S... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 45mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Compass. Part of MAXIMIS Pedicle Screw Spinal Fixation Syste... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 120mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 70mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS 500mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fix... Devices are not consistent with Quality System Requirements. Class II
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal... Devices are not consistent with Quality System Requirements. Class II

View all 144 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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