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LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size ... (Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany) – increased force may be required to re... (2023)

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Moderate

FDAJul 3, 2023Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Wireless Foot Switch distributed with Philips Allura Xper... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – loss of availability of the wireless ... (2023)

Loss of availability of the wireless foot switch during procedures.

Moderate

FDAJun 30, 2023Nationwide

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LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size ... (Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany) – increased force may be required to re... (2023)

Wireless Foot Switch distributed with Philips Allura Xper... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – loss of availability of the wireless ... (2023)

LifeSPARC Pump (part number 5800-0000) contained within T... (Cardiac Assist, Inc) – epoxy used during manufacturing of th... (2023)

Impella RP Flex with SmartAssist intracardiac microaxial ... (Abiomed, Inc.) – a higher than expected rate of throm... (2023)

ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000... (Maquet Cardiovascular, LLC) – the standard blade may not securely l... (2023)

stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to... (Stryker Corporation) – there is potential the device inside ... (2023)

ACCESSRAIL Platform (Standard Blade) Part Number SB-1000,... (Maquet Cardiovascular, LLC) – the standard blade may not securely l... (2023)

stryker 3.0MM Precision Neuro Match Head, REF 5820-107-53... (Stryker Corporation) – there is potential the device inside ... (2023)

ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-1000... (Maquet Cardiovascular, LLC) – the standard blade may not securely l... (2023)

Infinity FMS Pak (Alcon Research, LTD.) – plastic contamination (2023)

Medtronic REF 46915 Duet External Drainage and Monitoring... (Medtronic Neurosurgery) – product labeling contains incorrect e... (2023)

ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S.... (Maquet Cardiovascular, LLC) – the standard blade may not securely l... (2023)

Centurion FMS Pak (Alcon Research, LTD.) – plastic contamination (2023)

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 c... – catheter center lumen was found to ha... (2023)

Legion FMS Pak (Alcon Research, LTD.) – plastic contamination (2023)

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis ... – catheter center lumen was found to ha... (2023)

Alcon Custom Pak (Alcon Research, LTD.) – plastic contamination (2023)

Constellation Procedure Pak (Alcon Research, LTD.) – plastic contamination (2023)

The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) ... (Stryker Corporation) – there is potential the device inside ... (2023)

Phaco Standalone Tips (Alcon Research, LTD.) – plastic contamination (2023)