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.
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 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
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
Part of a larger recall action
This product is one of 3 recalled by ADRIA SRL 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 3 products in this recall →Related recalls
Same manufacturer · ADRIA SRL
See all →- HighHerniatome lumbar surgical instrument recalled for sterilization failure
FDA (Devices) · 2021-10-27
- HighHerniatome Surgical Device Recalled Due to Sterilization Failure
FDA (Devices) · 2021-10-27
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