DeRoyal Industries Inc: Medical Device Recall in 2021 - (Recall #: Z-1139-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 25, 2021

Date Posted: March 3, 2021

Recall Number: Z-1139-2021

Event ID: 87218

Reason for Recall:

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

Status: Terminated

Product Quantity: 1084 packs

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.

Voluntary or Mandated:

Voluntary: Firm initiated