Instructions for Use for the following Leksell recall
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter…
Why was Instructions for Use for the following Leksell recalled?
The incorrect IFU was distributed with the devices.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: (1) 07340048301305; (2) 07340048300285; (3) 07340048301220; (4) 07340048301145; (5) 07340048300315; (6) 07340048308618; (7) 07340048308632; (8) 07340048308571; (9) 07340048308564; (10 07340048308601; (11) 07340048308625; and (12) 07340048306348.
- Product
- Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter…
- Recalling firm
- Elekta Instrument AB
- Quantity
- 70 devices
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS, MA, MD, MI, MN, MO, MS, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. There was also government distribution.
- Recall date
- April 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)