The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1138-2021·Announced 2021-03-03

DeRoyal Recalls Non-Sterile Sternum Saw Blades in Surgical Packs

DeRoyal Industries is recalling 309 CV Basin Set Packs because the included sternum saw blades are not sterile.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by non-sterile surgical instruments) fall under the Severe category.

Plain-English summary

DeRoyal Industries Inc is recalling 309 CV Basin Set Packs, which are custom surgical procedure packs. The recall is due to the discovery that the sternum saw blades included in these packs are not sterile. The affected products are identified by REF numbers 89-7935.11 through 89-7935.16 and various specific lot codes and expiration dates listed in the agency record.

The non-sterile status of the saw blades is indicated by a green non-sterile sticker on the surgical saw blade. The affected packs were distributed to distributors in Oklahoma, Michigan, and Texas. The FDA has classified this recall as Class II, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare facilities and distributors should stop using the affected CV Basin Set Packs immediately. Users should check their inventory for the specific REF numbers and lot codes listed in the recall notice. If you have used these packs, you should contact your healthcare provider for guidance.

The recalled product

Product
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.
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
309

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 (13)

  • 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

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 →

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