SpineFrontier, Inc.
Complete recall history across all FDA and CPSC categories — 33 total recalls
SpineFrontier, 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 (33)
FDA medical device enforcement actions by SpineFrontier, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 13, 2019 | A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part ... | There is a potential for the driver to bind up when attempting to advance the... | Class II |
| Mar 5, 2015 | SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique... | The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Scre... | Class II |
| Dec 19, 2014 | lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 | A crack may develop in the handle to the Inline Persuader, which may progress... | Class II |
| Nov 20, 2013 | Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to sec... | Mismarked and unmarked screws | Class II |
| Nov 20, 2013 | Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the In... | Mismarked and unmarked screws | Class II |
| Nov 20, 2013 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-801... | Screw inserters may not mate properly with hex interface of the screws. | Class II |
| Nov 20, 2013 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-801... | Screw inserters may not mate properly with hex interface of the screws. | Class II |
| Nov 20, 2013 | Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to s... | Mismarked and unmarked screws | Class II |
| Nov 20, 2013 | Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to se... | Mismarked and unmarked screws | Class II |
| Nov 20, 2013 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-8... | Screw inserters may not mate properly with hex interface of the screws. | Class II |
| Oct 18, 2013 | PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw im... | During routine servicing, it was discovered that one 8mmx55mm Reset screw was... | Class II |
| Sep 24, 2013 | Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81... | Handles and heads may not be compatible. | Class II |
| Sep 24, 2013 | Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates tha... | Handles and heads may not be compatible. | Class II |
| Sep 24, 2013 | Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-8... | Handles and heads may not be compatible. | Class II |
| Sep 11, 2013 | PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. | Bone Probes used to create a pathway in pedicle bone were manufactured and ma... | Class II |
| Aug 28, 2013 | S-LIFT Extension Shims Extension shims are manufactured from grade 5 titaniu... | Fit variation among all lots of S-LIFT extension shims with corresponding ret... | Class II |
| Jun 21, 2013 | Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized f... | Difficulty removing screws from the Invue caddies. | Class II |
| May 24, 2013 | S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an op... | The outer sleeve would not fit over the S-LIFT Inserter assembly because the ... | Class II |
| May 17, 2013 | BASE, S-LIFT Instrument Case Product Usage: System cases are designed to... | The S-LIFT Instrument Case contained a bracket with peeling nylon coating. | Class II |
| May 10, 2013 | Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conju... | Device design. | Class II |
| May 7, 2013 | InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Us... | Potential for set screw to be come deformed. | Class II |
| Apr 25, 2013 | S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are... | Malfunction of slap hammer. | Class II |
| Apr 22, 2013 | Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan ... | Non-toxic inks, used on the silk screen graphics of the case bases and lids, ... | Class II |
| Mar 14, 2013 | Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserter... | Inserters have a set screw that fixes a collar to the inserter. The screw se... | Class II |
| Nov 9, 2012 | Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A ... | Prior to use in surgery, the Drill Guides were presenting noticeable degrees ... | Class II |
| Oct 5, 2012 | Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B T... | Two sections that are designated for the 8mm and 9mm screws were switched; th... | Class II |
| Aug 29, 2012 | T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-hand... | During an operation the strike plate of a T-Handle loosened and separated fro... | Class II |
| Aug 28, 2012 | Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compresso... | Inspan Compressors may break at weld causing a loss of compression | Class II |
| Aug 22, 2012 | S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223... | When using the optional S-LIFT (also known as S-LIF) Implant Guides without s... | Class II |
| May 9, 2012 | Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user ... | The nipple of the tipped driver broke off when surgeons were attempting to in... | Class II |
| Dec 30, 2011 | KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods a... | One of the rods in each of two test constructs did not meet fatigue requireme... | Class II |
| Dec 23, 2011 | SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Inte... | It has been verified through field use that there are two possible breakages ... | Class II |
| May 10, 2008 | Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to p... | During two separate occasions an impactor plate on the handle broke off while... | 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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