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Recall Observatory FDA recall evidence

Device product

CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.

Z-1138-2021

January 25, 2021

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 87218
Status
Terminated
Classification
Class II
Quantity
309 packs
Official record key
device-enforcement:Z-1138-2021

Official wording

Reason: Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.

Code information: a) 89-7935.11, Lot codes: 48285959 exp 12/21/2022 b) 89-7935.12, Lot codes: 49057260 exp 5/1/2023, 49239952 exp 4/1/2023, 49481001 exp 6/1/2023, 49603726 exp 8/1/2023, 49864125 exp 7/1/2021 c) 89-7935.13, Lot codes: 50404644 exp 11/1/2021, 50698398 exp 11/1/2023 d) 89-7935.14, Lot codes: 5125317 exp 6/1/2022 e) 89-7935.15, Lot codes: 51305461 exp 2/1/2024, 51983318 exp 2/1/2024 f) 89-7935.16, Lot codes: 53324463 exp 12/1/2024

Distribution pattern: Distributors in OK, MI, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.