The Recall Desk
HighFDA (Devices)·Z-0633-2023·Announced 2022-12-21

DeRoyal Laminectomy Spinal Fusion Pack Recalled by FDA (Class II)

DeRoyal Industries voluntarily recalled 100 kits of its laminectomy spinal fusion pack after identifying a device defect. The recall affects medical facilities in 23 states.

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: This is a Class II recall of a surgical spinal implant device, which is a risk-of-harm product. Although no reported injuries are documented in the source, the defect poses potential serious harm to patients undergoing surgery.

Plain-English summary

DeRoyal Industries Inc. has voluntarily recalled the DeRoyal Laminectomy Spinal Fusion Pack (REF 89-9105.10). The recall involves 100 kits with lot number 57757928, expiring September 1, 2024, and was initiated on November 3, 2022.

The recalled kits were 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.

Healthcare providers who use this product should identify whether they have received the affected lot number. This is an ongoing Class II recall.

The recalled product

Product
DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Orthopedic / Spinal Implant
Hazard
  • device-defect

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 (1)

  • Lot Numbers: Lot 57757928 exp 9/1/2024

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category