Herniatome lumbar surgical instrument recalled for sterilization failure
ADRIA SRL recalls Herniatome surgical instruments (Model 5091745) distributed to New Jersey and New York due to sterilization process parameter failures.
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 medical device recall with a sterilization process failure—a significant quality defect for a surgical instrument used in invasive procedures. No illnesses, injuries, or deaths have been reported, making the hazard theoretical. The device qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
ADRIA SRL is recalling the Herniatome, 17G x 15cm, Lumbar Type (Model 5091745) with Lot Number ZV0994 AD0314/20 AD0316/20. The recall was initiated because the contract sterilizer notified the manufacturer that sterilization process parameters were not followed during production.
The affected devices were distributed to healthcare facilities in New Jersey and New York. These surgical instruments are used in lumbar spine procedures.
Improper sterilization of surgical instruments increases the risk of infection to patients. Healthcare facilities that received these devices should quarantine the affected units immediately and consult with ADRIA SRL and their surgical teams regarding patient notification and appropriate follow-up care.
The recalled product
- Product
- Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
- 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: ZV0994 AD0314/20 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 Surgical Device Recalled Due to Sterilization Failure
FDA (Devices) · 2021-10-27
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