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Browse Device Recalls

33 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 33 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 33 FDA device recalls.

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DateProductReasonClassFirm
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 intervertebral body... Class II SpineFrontier, Inc.
Mar 5, 2015 SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique... The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used... Class II SpineFrontier, Inc.
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 if the user continu... Class II SpineFrontier, Inc.
Nov 20, 2013 Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to sec... Mismarked and unmarked screws Class II SpineFrontier, Inc.
Nov 20, 2013 Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the In... Mismarked and unmarked screws Class II SpineFrontier, Inc.
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 SpineFrontier, Inc.
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 SpineFrontier, Inc.
Nov 20, 2013 Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to s... Mismarked and unmarked screws Class II SpineFrontier, Inc.
Nov 20, 2013 Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to se... Mismarked and unmarked screws Class II SpineFrontier, Inc.
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 SpineFrontier, Inc.
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 assembled with an 8... Class II SpineFrontier, Inc.
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 SpineFrontier, Inc.
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 SpineFrontier, Inc.
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 SpineFrontier, Inc.
Sep 11, 2013 PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect sp... Class II SpineFrontier, Inc.
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 retractor blades. The f... Class II SpineFrontier, Inc.
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 SpineFrontier, Inc.
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 hole at the top of t... Class II SpineFrontier, Inc.
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 SpineFrontier, Inc.
May 10, 2013 Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conju... Device design. Class II SpineFrontier, Inc.
May 7, 2013 InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Us... Potential for set screw to be come deformed. Class II SpineFrontier, Inc.
Apr 25, 2013 S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are... Malfunction of slap hammer. Class II SpineFrontier, Inc.
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, and caddy lids, were... Class II SpineFrontier, Inc.
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 set can loosen and fal... Class II SpineFrontier, Inc.
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 of denting and/or be... Class II SpineFrontier, Inc.
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; the holes that hold th... Class II SpineFrontier, Inc.
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 from the T-Handle. Class II SpineFrontier, Inc.
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 SpineFrontier, Inc.
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 stops, there is a kno... Class II SpineFrontier, Inc.
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 insert the screw. Class II SpineFrontier, Inc.
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 requirement as outlined in AS... Class II SpineFrontier, Inc.
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 that may occur when ... Class II SpineFrontier, Inc.
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 being struck by a m... Class II SpineFrontier, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.