Lase DiscectomLase Discectomy Device Kit recall: Sterility Concern
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Why was Lase DiscectomLase Discectomy Device Kit recalled?
The sterile barrier seal may be compromised.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Numbers 1100-002 and 1100-002 SHORT; Serial Numbers 64139 through 65022
- Product
- Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
- Recalling firm
- Clarus Medical, Llc
- Quantity
- 858 units
- Distribution
- Distribution in US - 18 accounts 1 foreign account
- Recall date
- September 8, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)