X Spine Systems Inc

Complete recall history across all FDA and CPSC categories — 7 total recalls

X Spine Systems Inc 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 (7)

FDA medical device enforcement actions by X Spine Systems Inc

Date Product Reason Class
May 17, 2016 Calix T PEEK Lumbar System, TLIF Rasp The trials and rasps used to prepare the surgical site for placement of the i... Class II
May 17, 2016 Calix P PEEK Lumbar System, PLIF Rasp The trials and rasps used to prepare the surgical site for placement of the i... Class II
May 17, 2016 Calix P PEEK Lumbar System, PLIF Trial The trials and rasps used to prepare the surgical site for placement of the i... Class II
May 17, 2016 Calix T PEEK Lumbar System, TLIF Trial The trials and rasps used to prepare the surgical site for placement of the i... Class II
Apr 7, 2015 Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine System... The Continuous Radius Rod should measure 50mm in length but actually measures... Class II
Mar 11, 2015 Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation devi... One lot of instruments have etched on the Yoke of the Pedicle Screw a laser m... Class II
Jul 11, 2014 Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the S... Revision B of the tissue shields of the device was 7 mm longer than the previ... Class II

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.

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