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HRIS ACET Cup (Howmedica) – seal integrity failure (2023)

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

Low

FDADec 22, 2023Nationwide• Howmedica Osteonics Corp.

Eleos Collar Stem (Onkos) – mislabeling problem (2023)

Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

Low

FDADec 22, 2023Nationwide• Onkos Surgical, Inc.

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HRIS ACET Cup (Howmedica) – seal integrity failure (2023)

Eleos Collar Stem (Onkos) – mislabeling problem (2023)

Aligned Ocular Pack (Windstone) – saline sterility concern (2023)

Aligned Closure Kit (Windstone) – saline sterility concern (2023)

Baxter Exactamix Pro (Baxter) – overfill software error (2023)

Aligned Lower Extremity Pack (Windstone) – saline sterility issue (2023)

GE Voluson Probe (GE Healthcare) – image artifact risk (2023)

HRIS ACET Cup (Howmedica) – seal integrity failure (2023)

Allograft Filler Tube (Musculoskeletal) – filling process risk (2023)

Allograft Filler Tube (Musculoskeletal) – filling process risk (2023)

Baxter Exactamix Pro (Baxter) – overfill software error (2023)

Henry Schein Masks (AMD Medicom) – production equipment problem (2023)

Phantom TTC Nail (Paragon 28) – pre-sterilization distribution (2023)

Terumo HydroPearl (MicroVention) – manufacturing process fault (2023)

Medline Blood Culture Bottle Kit (Medline) – kit quality issue (2023)

Phantom TTC Nail (Paragon 28) – pre-sterilization distribution (2023)

Phantom TTC Nail (Paragon 28) – pre-sterilization distribution (2023)

Surgilon Sutures (Unknown) – gamma radiation strength issue (2023)

Henry Schein Masks (AMD Medicom) – production equipment problem (2023)

Medline Blood Culture Tray (Medline) – kit quality issue (2023)