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EMPOWR 3D Knee Tibial Insert (Unknown) – Surgical Parts Swap (2023)

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

Low

FDAAug 22, 2023Nationwide

3M Attest Biological Indicator (3M) – Multiple Lot Defects (2023)

Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C.

Moderate

FDAAug 22, 2023Nationwide• 3M Company Health Care Business 3m Center

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EMPOWR 3D Knee Tibial Insert (Unknown) – Surgical Parts Swap (2023)

3M Attest Biological Indicator (3M) – Multiple Lot Defects (2023)

Smiths Medical Portex Bivona Tracheostomy Tube (Smiths Medical) – Incorrect Expiration (2023)

3M Attest Steam Challenge Pack (3M) – Multiple Lot Defects (2023)

Apellis Injection Kit (Apellis) – Needle Characteristic Deviation (2023)

Gladiator Wrist Orthosis (North Coast Medical) – Undeclared Latex (2023)

BD Pyxis MedBank Software (CareFusion) – Medication Tracking Error (2023)

Constellation Vision System (Alcon) – Circuit Board Risk (2023)

OPMI Lumera 300 (Carl Zeiss) – Missing Suspension Screw (2023)

Exoplan Software (Exocad) – Export Filtering Error (2023)

Patient Information Center iX (Philips) – Graphics Driver Crash (2023)

SOZO Bilateral Arm Software (Unknown) – Lymphedema Detection Limitation (2023)

Presource Fistulogram Pack (Cardinal Health) – Recalled Components (2023)

Medfusion Plunger Case (Smiths Medical) – Occlusion Detection Fault (2023)

Medfusion Syringe Pump (Smiths Medical) – Occlusion Detection Fault (2023)

Presource PBDS Kit (Cardinal Health) – Recalled Components (2023)

Gallant VR Defibrillator (Abbott) – Bluetooth Malfunction (2023)

Presource Portacath Pack (Cardinal Health) – Recalled Components (2023)

Medfusion Plunger Float Plate (Smiths Medical) – Occlusion Detection Fault (2023)

Medfusion 3500 Syringe Pump (Smiths Medical) – Occlusion Detection Fault (2023)