Z-1139-2021Class II

Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical...

Name: Z-1139-2021 Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical...
Creator: DeRoyal Industries Inc
Published: 2021-01-25
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2021-01-25 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of 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 on 2021-01-25. FDA classified it as Class II and gives the reason as "Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1139-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-25
Posted: 2021-02-19
Terminated: 2022-07-21
Recalling firm: DeRoyal Industries, Inc.
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.
Product code: LRO General Surgery Tray
Reason for recall: Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 1084 packs
Distribution: Distributors in OK, MI, and TX.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1139-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1138-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-19
Z-1139-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-19
Z-1140-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-19

Product code LRO

K842648Class IIGeneral Surgery TrayDeroyal Industries, Inc. / cleared 1984-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)