The Recall Desk
HighFDA (Devices)·Z-1139-2021·Announced 2021-03-03

DeRoyal Open Heart Packs Recalled Due to Non-Sterile Sternum Saw Blades

DeRoyal Industries is recalling 1,084 Open Heart Packs because the included sternum saw blades were not sterile, despite being part of a surgical procedure pack.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a critical safety feature (sterility) is missing, posing a risk of harm during surgery, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

DeRoyal Industries Inc is recalling 1,084 Open Heart Packs (REF numbers 89-7483.07, 89-7483.08, 89-7483.09, and 89-7483.10). These are custom surgical procedure packs that include sternum saw blades. The recall was initiated because the sternum saw blades within these packs were not sterile. The affected surgical saw blades are identified by a green non-sterile sticker.

The affected products were distributed to distributors in Oklahoma, Michigan, and Texas. Specific lot numbers and expiration dates are listed in the official recall record, ranging from March 2021 to November 2022.

Healthcare facilities and distributors should stop using the affected packs and contact DeRoyal Industries for further instructions. Consumers are not directly affected as these are professional medical devices distributed to healthcare providers.

The recalled product

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.
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,084

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 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

Distributed in 3 states:

Part of a larger recall action

This product is one of 3 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · DeRoyal Industries Inc

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Same hazard · non sterile device

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