The Recall Desk
ModerateFDA (Devices)·Z-0625-2023·Announced 2022-12-21

Voluntary recall of DeRoyal ACDF Pack surgical implant kits

A voluntary recall of 45 DeRoyal ACDF Pack surgical implant kits affects multiple US states. The recall reason was not specified in the available notice.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II device recall with no reported illnesses or injuries in the source text. Per the severity rubric, Class II recalls without hospitalization reports and with voluntary status are classified as Moderate (2).

Plain-English summary

DeRoyal Industries Inc. initiated a voluntary recall of the DeRoyal ACDF Pack (REF 89-8779.03), a medical device kit used in anterior cervical fusion surgery, in November 2022. The recall affects 45 kits bearing two lot numbers: Lot 56188891 (exp. 12/1/2023) and Lot 56675066 (exp. 7/1/2023). These kits were distributed across 23 US states.

The specific reason for the recall was not disclosed in the available recall notice.

Healthcare facilities receiving these kits should contact DeRoyal Industries directly for further instructions. The recall is classified as FDA Class II. For complete details, consult the official FDA recall notice Z-0625-2023.

The recalled product

Product
DeRoyal ACDF PACK, REF 89-8779.03
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical implant kit

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 (2)

  • Lot Numbers: Lot 56188891 exp12/1/2023
  • Lot 56675066 exp 7/1/2023

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category