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FUSION Dual Pump Packs (Johnson & Johnson) – Weld Protrusion (2022)

Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

Moderate

FDADec 7, 2022FL, IL, MN +5 more• Johnson & Johnson Surgical Vision, Inc.

Rotating Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury

High

FDADec 7, 2022Nationwide

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FUSION Dual Pump Packs (Johnson & Johnson) – Weld Protrusion (2022)

Rotating Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

Single-Use Packs (Johnson & Johnson) – Weld Protrusion (2022)

Veritas Infusion Packs (Johnson & Johnson) – Weld Protrusion (2022)

Adult Craniotome (Anspach) – Ball Bearing Failure (2022)

Identity Shoulder Planer (Zimmer) – Training Unusability (2022)

Large Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

Adult Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

Medline Pain Tray (Medline) – Sterility Packaging (2022)

Mahurkar Dialysis Catheter (Unknown) – Hub Leakage (2022)

Pediatric Craniotome (Anspach) – Ball Bearing Failure (2022)

Pediatric Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

Garbin Ventilator (Philips) – Foam Separation (2022)

IMMULITE 2000 Thyroglobulin (Siemens) – Sensitivity Issue (2022)

MobiCT-32 AIRO Scanner (Mobius) – User Movement Risk (2022)

Adult Craniotome (Anspach) – Ball Bearing Failure (2022)

IMMULITE 2000 Thyroglobulin (Siemens) – Sensitivity Issue (2022)

Large Rotating Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

Trilogy 100 Ventilator (Philips) – Foam Separation (2022)

NexGen Tibial Component (Zimmer) – Surgical Component Issue (2022)