Ebi, Llc

Complete recall history across all FDA and CPSC categories — 13 total recalls

Ebi, 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 (13)

FDA medical device enforcement actions by Ebi, Llc

Date Product Reason Class
Mar 22, 2024 Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the... Damage to the lead wire sheath (black cable) component and causing exposure o... Class II
Mar 22, 2024 20" Lead Wires, Replacement Part Number: 1067724-2 Damage to the lead wire sheath (black cable) component and causing exposure o... Class II
Mar 22, 2024 Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for ... Damage to the lead wire sheath (black cable) component and causing exposure o... Class II
Mar 22, 2024 48" Lead Wires, Replacement Part Number: 1067724-4 Damage to the lead wire sheath (black cable) component and causing exposure o... Class II
Nov 11, 2014 Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-53... A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Lo... Class II
Oct 8, 2014 Cypher MIS Screw System-The system includes screws, various types and sizes o... Inoperative screw head seat splay and/or fracture as a result of positioning ... Class II
May 15, 2014 Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrumen... The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip... Class II
Sep 24, 2013 Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Steri... Biomet received a complaint on 5/20/2013 reporting that the tip of the instru... Class II
Aug 22, 2013 BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System... Polaris Translation Screw Failures were recently reported to Biomet Spine. T... Class II
Aug 13, 2013 Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Sc... Several complaints were reported to exhibit screw head splay in the Cypher MI... Class II
Apr 9, 2013 Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an in... Several complaints were recorded regarding one of the three screws driving th... Class II
Feb 7, 2013 Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-50017... Increased risk of failure at the driver tip during screw insertion or removal. Class II
Sep 29, 2012 Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 Broken screw insertor hardness was measured and found to be below the accepta... 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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