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EMPOWR Acetabular Liner (Unknown) – Implant Mix-Up (2022)

Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.

Moderate

FDAAug 12, 2022Nationwide

Olympus PowerSeal 5MM Sealer (Olympus) – Rotation Knob Issue (2022)

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

Moderate

FDAAug 12, 2022Nationwide• Olympus Corporation of the Americas

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EMPOWR Acetabular Liner (Unknown) – Implant Mix-Up (2022)

Olympus PowerSeal 5MM Sealer (Olympus) – Rotation Knob Issue (2022)

Olympus PowerSeal 5MM Sealer (Olympus) – Rotation Knob Issue (2022)

Olympus PowerSeal 5MM Sealer (Olympus) – Rotation Knob Issue (2022)

Humidifier Kit (CooperSurgical) – Sterile Barrier Breach (2022)

IMMULITE Thyroid Test (Siemens) – Negative Bias (2022)

GXL Acetabular Liners (Exactech) – Packaging Defect (2022)

VenaCure EVLT Kit (Angiodynamics) – Fiber Dimension Problem (2022)

Artis Pheno X-Ray System (Siemens) – Hardware Issue (2022)

Artis Q X-Ray System (Siemens) – Hardware Issue (2022)

Artis Icono X-Ray System (Siemens) – Hardware Issue (2022)

Early Bird Bleed Monitoring System (Saranas) – Device Power Fault (2022)

Dewei DNA/RNA Kit (Unknown) – FDA Authorization (2022)

Boston Scientific Guider Softip (Boston Scientific) – Tip Curve Mismatch (2022)

BioZorb LP Marker (Hologic) – Expiration Label (2022)

COVID-19 Ag Test (Jiangsu Well) – Unauthorized Distribution (2022)

CoViPoint COVID Test (GS Biomark) – FDA Authorization (2022)

Stryker USB Converter (Mako) – Potential Failure (2022)

PDS II Suture (Ethicon) – Material Error (2022)

Sensation Insertion Kit (Datascope) – Dilator Size (2022)