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Calibrate CCX Interbody System (Alphatec) – Implant Collapse Risk (2024)

Complaints have been received regarding post-operative implant collapse.

FDADec 15, 2024Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

Panther Fusion GBS Assay (Hologic) – Pouch Seal Weakness (2024)

Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.

FDADec 13, 2024AR, CA, CT +17 more• Hologic, Inc.

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Calibrate CCX Interbody System (Alphatec) – Implant Collapse Risk (2024)

Panther Fusion GBS Assay (Hologic) – Pouch Seal Weakness (2024)

IMed Dressing Change Kit (Trinity Sterile) – Package Sterility Risk (2024)

Clobazam Tablets (Amerisource) – Foreign Tablet Contamination (2024)

Wolf-Pak Dressing Change Kit (Trinity Sterile) – Package Sterility Risk (2024)

Tacy Medical Dressing Change Tray (Trinity Sterile) – Package Sterility Risk (2024)

VALITUDE CRT-P (Boston Scientific) – Safety Mode Potential (2024)

PROPONENT DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

ESSENTIO DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

VISIONIST CRT-P (Boston Scientific) – Safety Mode Potential (2024)

ALTRUA 2 DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

SenTiva Microburst VNS Generator (LivaNova) – Stimulation Interruption Risk (2024)

Select Series Arterial Cannula (Medtronic) – Incorrect Labeling (2024)

SenTiva VNS Generator (LivaNova) – Stimulation Interruption Risk (2024)

Impella RP Flex with SmartAssist (Abiomed) – Optical Sensor Damage (2024)

EOPA Arterial Cannula (Medtronic) – Incorrect Labeling (2024)

Acetaminophen Tablets (Akron Pharma) – Incorrect Tablet Imprint (2024)

Acetaminophen Extra Strength 500mg 1000ct (Akron Pharma) – Incorrect Tablet Imprint (2024)

Nhan Sam Tuyet Lien Capsules (Buy-Herbal) – Undeclared Medications (2024)

Diphenhydramine HCl 50mg (Akron Pharma) – Incorrect Tablet Imprint (2024)