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Browse Device Recalls

211 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 211 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 211 FDA device recalls.

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DateProductReasonClassFirm
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, ... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Aug 31, 2017 Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulde... Potentially mislabeled. Class II Exactech, Inc.
Aug 31, 2017 Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder... Potentially mislabeled. Class II Exactech, Inc.
Jul 11, 2017 Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool Vix Bit may fracture during use. Class II Exactech, Inc.
Jun 23, 2017 Truliant Tibial Trial Handle. To assist the surgeon in the implantation of... The Truliant Tibial Trial Handle's pin may disassociate from the main body. Class II Exactech, Inc.
May 25, 2017 Logic Fit Tibial Tamp Head The firm determined that the labeling (surgical technique) should be updated to clarify the prope... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-2... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01 Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Cat... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: ... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 22, 2017 Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in th... The firm determined that the labeling (surgical technique) should be updated to clarify the prope... Class II Exactech, Inc.
May 16, 2017 Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactec... Possible inner labeling and packaged device not matching the outer label on the box. Class II Exactech, Inc.
May 16, 2017 Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exacte... Possible inner labeling and packaged device not matching the outer label on the box. Class II Exactech, Inc.
Apr 7, 2017 Exactech Optetrak Logic CC 15mm Tibial Augment Screws Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged ... Class II Exactech, Inc.
Nov 7, 2016 Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte,... Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ... Class II Exactech, Inc.
Nov 7, 2016 Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ... Class II Exactech, Inc.
Nov 7, 2016 AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +... Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ... Class II Exactech, Inc.
Oct 25, 2016 Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver. Class II Exactech, Inc.
May 26, 2016 Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femor... Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the... Class II Exactech, Inc.
May 26, 2016 Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femor... Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11,... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabula... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral St... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabula... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral St... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Sep 28, 2015 Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Su... Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella ... Class II Exactech, Inc.
Sep 23, 2015 Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset,... Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating. Class II Exactech, Inc.
May 21, 2015 Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical ... Shipped to a single consignee prior to completion of final inspection. Class II Exactech, Inc.
May 21, 2015 Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpo... Shipped to a single consignee prior to completion of final inspection. Class II Exactech, Inc.
Feb 13, 2015 Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic... Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed... Class II Exactech, Inc.
Oct 9, 2014 Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, C... Mislabeled Class II Exactech, Inc.
Mar 7, 2014 NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Ca... The femoral stem is lacking specified plasma coating. Class II Exactech, Inc.
Jan 6, 2014 Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cer... The products have been identified to contain springs which have been manufactured with type-304 s... Class II Exactech, Inc.
Sep 11, 2013 ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm ... Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in... Class II Exactech, Inc.
May 30, 2013 Exactech Articulated Driver A nonpowered hand-held device intended for me... When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift ou... Class II Exactech, Inc.
Feb 1, 2013 Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer a... A dimensional mismatch was identified which can potentially allow for interference between devices. Class II Exactech, Inc.
Nov 5, 2012 Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, ... Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation C... Class II Exactech, Inc.
Nov 5, 2012 Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMW... Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation C... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total ... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total ... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Revers... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Tot... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine interver... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, 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.