DeRoyal Industries Inc: Medical Device Recall in 2021 - (Recall #: Z-1138-2021)

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:

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.

Product Classification:

Class II

Date Initiated: January 25, 2021

Date Posted: March 3, 2021

Recall Number: Z-1138-2021

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: 309 packs

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.

Voluntary or Mandated:

Voluntary: Firm initiated