—#185560

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.

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) 89-7483.07, 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

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 #185560. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.