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BIOKNOTLESS Plus Anchor (DePuy Mitek) - Inserter Tip Fragment Risk (2023)

IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time

High

FDAApr 13, 2023Nationwide• DePuy Mitek, Inc., a Johnson & Johnson Co.

Banana Nut Mini Treats (Highkey) – Undeclared Egg (2023)

The firm was notified that a consumer had an allergic reaction to their product. The product did not list egg on the label.

Class IHigh

FDAApr 13, 2023CA, CO, FL +4 more• SUMMIT NATURALS INC

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BIOKNOTLESS Plus Anchor (DePuy Mitek) - Inserter Tip Fragment Risk (2023)

Banana Nut Mini Treats (Highkey) – Undeclared Egg (2023)

C-Semaglutide Injection (Vital Care) – Sterility Concern (2023)

TRIATHLON X3 Tibial Bearing Insert (Howmedica) - Mislabeling Issue (2023)

Highkey Mini Treats (Summit Naturals) – Undeclared Egg (2023)

D-Stat Flowable Hemostat (Teleflex) - Expired Diluent Vial (2023)

Incisive CT Plus (Philips) - Image Orientation Risk (2023)

Incisive CT Power (Philips) - Image Orientation Risk (2023)

Incisive CT (Philips) - Image Orientation Risk (2023)

Ultraview SL Command Module (Spacelabs) - Parameter Processing Issue (2023)

Codman Cranial Hand Drill (Integra) - Discoloration Risk (2023)

Bard Mission Biopsy Instrument Kit (Bard) - Instrument Size Mismatch (2023)

StealthStation Cranial Software (Medtronic) - Depth Gauge Graphic Issue (2023)

StealthStation Cranial Software (Medtronic) - Exam Procedure Problem (2023)

Admelog (Sanofi-Aventis) – Sterility Seal Issue (2023)

Henry Schein Chairside Reline Kit (Keystone) - Mislabeling Issue (2023)

Ortholoc 3Di Fusion Plate (Wright Medical) - Marking Description Error (2023)

Reliance Vision Washer/Disinfector (Steris) - Electrical Component Risk (2023)

Over-Head Ceiling Tube Support (Shimadzu) - Bolt Fastening Issue (2023)

Blue Rhino G2 Tracheostomy Introducer (Cook) – Connection Failure (2023)