The Recall Desk
HighFDA (Devices)·Z-0692-2023·Announced 2022-12-21

FDA Class II Recall of DeRoyal Posterior Spine Surgical Packs

DeRoyal Industries voluntarily recalled 1,196 posterior spine surgical packs distributed across 23 states. The specific reason for the recall was not documented.

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 FDA recall for a surgical spine device, which is classified as a risk-of-harm product. With no reported injuries and no specified hazard documented, the severity is rated High per the rubric for unspecified-hazard medical devices.

Plain-English summary

DeRoyal Industries Inc has voluntarily recalled 1,196 units of the DeRoyal CMC POSTERIOR SPINE PACK, model REF 89-10570.01, a medical device used in spinal surgical procedures.

The recalled units were distributed across 23 states: 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. The affected devices are identified by specific lot numbers with expiration dates ranging from February 2023 to March 2024.

This is a Class II FDA recall initiated voluntarily by the manufacturer. The specific reason for the recall was not provided in the available documentation. The recall notice does not report any associated injuries or illnesses.

Those with inventory of the recalled device should contact DeRoyal Industries Inc directly for instructions regarding device return, replacement, or other corrective actions.

The recalled product

Product
DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Orthopedic
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 (13)

  • Lot Numbers: Lot 56190288 exp 8/1/2023
  • Lot 56224943 exp 8/1/2023
  • Lot 56432718 exp 2/1/2023
  • Lot 56432726 exp 8/1/2023
  • Lot 56639065 exp 8/1/2023
  • Lot 56906961 exp 8/1/2023
  • Lot 57051271 exp 8/1/2023
  • Lot 57228161 exp 8/1/2023
  • Lot 57393491 exp 1/1/2024
  • Lot 57488967 exp 3/1/2024
  • Lot 57679350 exp 3/1/2024
  • Lot 57685371 exp 3/1/2024
  • Lot 57751551 exp 3/1/2024

Distribution

Distribution scope not specified by the agency.

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