The Recall Desk
HighFDA (Devices)·Z-0146-2022·Announced 2021-10-27

Herniatome Surgical Instrument Recalled Due to Sterilization Process Failure

ADRIA SRL recalls Herniatome cervical surgical instruments (Model 5091749) due to sterilization process parameter failures. Products distributed to NJ and NY.

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 Class II recall involves a sterilization process failure on a surgical instrument, presenting a theoretical risk of infection. No illnesses or injuries are reported in the source material.

Plain-English summary

ADRIA SRL is recalling the Herniatome, 17G x 9cm, Cervical Type (Model Number 5091749) across affected lot numbers AD0063/20, AD0313/20, and AD0302/20.

The recall was initiated after the contract sterilizer notified the manufacturer that process parameters of the sterilization cycles were not followed. Proper sterilization is critical for surgical instruments to prevent infection and ensure patient safety during use.

The affected products were distributed to New Jersey and New York. Healthcare providers and patients who may have received this device should contact ADRIA SRL or the FDA for further guidance.

The recalled product

Product
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Manufacturer
ADRIA SRL
Category
Medical Device — Surgical Instrument
Hazard
  • sterilization-failure
  • infection-risk

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 Number: AD0063/20 AD0313/20 AD0302/20

Distribution

Distributed in 2 states:

  • NJ
  • NY

Related recalls

Same category