—#185567

Product

Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K842648
Affected lot / code info: a) 89-9194.07, Lot Numbers; 47782581 exp 5/1/2021 b) 89-9194.09, Lot Numbers: 50224694 exp 9/1/2023, 50326092 exp 9/1/2023, 50582301 exp 9/1/2023, 50795307 exp 11/1/2023, 51008862 exp 11/1/2023, 51153103 exp 11/1/2023 c) 89-9194-10, Lot Numbers: 51434221 exp 11/1/2023, 51881522 exp 11/1/2023 d) 89-9194-11, Lot Numbers: 52175785 exp 8/1/2022, 52849153 exp 11/1/2023, 53220664 exp 2/1/2025, 53327306 exp 2/1/2025, 53409521 exp 9/1/2023, 53565355 exp 12/1/2024

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

DeRoyal issued their recall on 01/25/2021 to the end user level by emailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the provided notice of credit form back to DeRoyal.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

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

Timeline

Recall initiated: 2021-01-25
Terminated: 2022-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185567. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.