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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.

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

Sterility assurance for saline included in surgical kits cannot be guaranteed.

Low

FDADec 22, 2023CA, FL, IL• Windstone Medical Packaging, Inc.

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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)

BMW I5 M60 (BMW) – sound generator malfunction (2023)

Mercedes-Benz Tourrider (Mercedes-Benz) – outlet safety issue (2023)

Volvo Bus 9700 (Volvo) – beacon lighting problem (2023)

Rosenbauer Commander (Rosenbauer) – electrical system fault (2023)

Mack Granite (Mack) – steering knuckle assembly risk (2023)

Ford F-150 (Ford) – axle hub problem (2023)

Winnebago Micro Minnie FLX (Winnebago) – spare tire risk (2023)

Freightliner M2 (Freightliner) – transmission indication fault (2023)

Prevost X3-45 VIP (Prevost) – cooling fan cable problem (2023)

New Flyer XE35 (New Flyer) – speed control software error (2023)

Kia Soul (Kia) – side airbag deployment issue (2023)

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