Myriad handpiece Tissue morcellator recall
Myriad handpiece Tissue morcellator
Why was Myriad handpiece Tissue morcellator recalled?
This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.
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?
13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994
- Product
- Myriad handpiece Tissue morcellator
- Recalling firm
- Nico Corp.
- Quantity
- 63 units
- Distribution
- US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.
- Recall date
- June 29, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)