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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 381–400 of 1,000 recalls

Class IITerminated

Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument

Nextremity Solutions

Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

February 10, 2022 · DeviceView details →

Class IITerminated

Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument

Nextremity Solutions

Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

February 10, 2022 · DeviceView details →

Class IITerminated

Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument

Nextremity Solutions

Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

February 10, 2022 · DeviceView details →

Class IITerminated

Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument

Nextremity Solutions

Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

February 10, 2022 · DeviceView details →

Class IITerminated

The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths

Wright Medical Technology, Inc.

Product was labelled with the incorrect manufacturing and distribution dates.

February 9, 2022 · DeviceView details →

Class IITerminated

VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

bioMerieux, Inc.

Invalid calibrations (out of range high) while using the product.

February 9, 2022 · DeviceView details →

Class IITerminated

Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Brius Technologies Inc.

Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.

February 7, 2022 · DeviceView details →

Class IITerminated

Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Brius Technologies Inc.

Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.

February 7, 2022 · DeviceView details →

Class IITerminated

PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U

B Braun Medical Inc

Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.

February 7, 2022 · DeviceView details →

Class IITerminated

Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Brius Technologies Inc.

Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.

February 7, 2022 · DeviceView details →

Class ITerminated

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.

ev3 Inc.

The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

February 4, 2022 · DeviceView details →

Class IIITerminated

TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

Cytocell Ltd.

May show unexpected locus specific signals in addition to those at 14q32.

February 4, 2022 · DeviceView details →

Class ITerminated

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.

ev3 Inc.

The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

February 4, 2022 · DeviceView details →

Class IITerminated

Cardiovascular Procedure Kit catalog # 76645 & 73806

Terumo Cardiovascular Systems Corp

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

February 3, 2022 · DeviceView details →

Class IITerminated

Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x

Philips Healthcare

Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed.

February 2, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.

BSN Medical Inc

The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.

February 1, 2022 · DeviceView details →

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