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Recall Observatory FDA recall evidence

Device product

Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.

Z-1139-2021

January 25, 2021

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 87218
Status
Terminated
Classification
Class II
Quantity
1084 packs
Official record key
device-enforcement:Z-1139-2021

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) 89-7483.07, Lot Numbers: 48535952 exp 3/1/2021, 48613789 exp 3/1/2021, 49330297 exp 7/1/2021, 49529669 exp 8/1/2021, 49852263 exp 9/1/2021 b) 89-7483.08, Lot Numbers: 50033361 exp 11/1/2021, 50404628 exp 12/1/2021, 50783200 exp 12/1/2021 c) 89-7483.09, Lot Numbers: 51021872 exp 12/1/2021, 51121460 exp 4/1/2022, 51284373 exp 4/30/2022, 51458898 exp 4/1/2022, 51701317 exp 7/1/2022 d) 89-7483.10, Lot Numbers: 51954402 exp 9/1/2022, 52183224 exp 9/1/2022, 52413069 exp 10/1/2022, 53117579 exp 10/1/2022, 53311005 exp 11/1/2022

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.