The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0667-2023·Announced 2022-12-21

DeRoyal ACDF surgical implant kit recall, Class II, reason undisclosed

DeRoyal is recalling 63 ACDF surgical implant kits distributed to 23 US states. This is a voluntary, Class II recall announced November 2022, with no reported illnesses or injuries.

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 3/5 (High).

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: This is a Class II device recall, indicating FDA assessment of potential for adverse health consequences. ACDF surgical implant kits are inherently high-risk medical devices where defects could cause patient harm. No reported illnesses or injuries have been documented, placing this in the 'risk-of-harm products where injury has not yet been reported' category per the rubric.

Plain-English summary

DeRoyal Industries Inc is recalling DeRoyal ACDF PACK PGYBK A PACK/B PACK (Reference 89-9997.06) surgical implant kits used in anterior cervical spine surgery. The recall affects 63 kits distributed to medical facilities in Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.

This is a voluntary, firm-initiated Class II recall. The recall was initiated on November 3, 2022, and officially classified by the FDA on December 15, 2022. Three lot numbers are affected, with expiration dates ranging from November 1, 2023, to June 1, 2024: Lot 56186481 (exp 11/1/2023), Lot 56431109 (exp 1/1/2024), and Lot 57189203 (exp 6/1/2024). The specific reason for the recall has not been disclosed in the FDA records.

No illnesses or injuries related to these products have been reported to the FDA. Healthcare providers and patients who received affected products should contact DeRoyal Industries for further instructions.

The recalled product

Product
DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Implant / Spine
Hazard
Affected units
63

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 (3)

  • Lot Numbers: Lot 56186481 exp 11/1/2023
  • Lot 56431109 exp 1/1/2024
  • Lot 57189203 exp 6/1/2024

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 156 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 156 products in this recall →

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