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Propel Mini Sinus Implant (Intersect ENT) – Label Error (2022)

Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.

Moderate

FDAOct 21, 2022Nationwide• Intersect ENT, Inc.

Busse Spine Injection Tray (Busse) – Surgical Drape Problem (2022)

Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable

Moderate

FDAOct 21, 2022TX• Busse Hospital Disposables, Inc.

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Propel Mini Sinus Implant (Intersect ENT) – Label Error (2022)

Busse Spine Injection Tray (Busse) – Surgical Drape Problem (2022)

Simplex HV Bone Cement (Howmedica) – Distribution Error (2022)

ROi Cervical Pack (ROi) – Surgical Drape Concern (2022)

ROi Shoulder Pack (ROi) – Surgical Drape Issue (2022)

ROi Vitrectomy Pack (ROi) – Surgical Drape Problem (2022)

ROi Total Hip Kit (ROi) – Surgical Drape Problem (2022)

ROi Shoulder Arthroscopy Kit (ROi) – Surgical Drape Concern (2022)

ROi ACDF Kit (ROi) – Surgical Drape Issue (2022)

ROi Spine Kit (ROi) – Surgical Drape Concern (2022)

ROi Shoulder Pack (ROi) – Surgical Drape Concern (2022)

ROi Major Ear Kit (ROi) – Surgical Drape Issue (2022)

ROi Foot Pack (ROi) – Surgical Drape Problem (2022)

ROi Vitrectomy Pack (ROi) – Surgical Drape Issue (2022)

ROi Total Joint Kit (ROi) – Surgical Drape Concern (2022)

ROi Cataract Kit (ROi) – Surgical Drape Issue (2022)

ROi Foot Pack (ROi) – Surgical Drape Concern (2022)

ROi DaVinci Pack (ROi) – Surgical Drape Problem (2022)

ROi Minor Neuro Kit (ROi) – Surgical Drape Concern (2022)

ROi Basic Neuro Kit (ROi) – Surgical Drape Issue (2022)