Herniatome Surgical Device Recalled Due to Sterilization Failure
ADRIA SRL is recalling herniatome surgical devices used in lumbar spinal procedures due to improper sterilization. The contract sterilizer failed to follow required process parameters, potentially compromising device sterility.
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 an FDA Class II recall of a high-risk surgical instrument used in invasive spinal procedures. While no illnesses or injuries have been reported, failure to properly sterilize surgical instruments poses a significant risk of patient harm through infection. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at the High level.
Plain-English summary
ADRIA SRL is recalling the Herniatome, 17G x 15cm, Lumbar Type with 20ga-30cm Introducer (Model Number 5091715, Lot AD0316/20). The sterilization process for this batch of devices did not meet required standards because the contract sterilizer failed to follow proper sterilization cycle parameters.
The herniatome is used in lumbar spinal procedures. Improper sterilization of surgical instruments used in invasive procedures poses a risk of patient infection or other complications.
The recalled devices were distributed to medical facilities in New Jersey and New York.
The recalled product
- Product
- Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
- 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: AD0316/20
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 Surgical Instrument Recalled Due to Sterilization Process Failure
FDA (Devices) · 2021-10-27
- HighHerniatome lumbar surgical instrument recalled for sterilization failure
FDA (Devices) · 2021-10-27
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