iTotal Identity Impactor Handle recall
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Why was iTotal Identity Impactor Handle recalled?
Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.
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 00810933030582 Lot D221301
- Product
- iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
- Recalling firm
- Conformis, Inc.
- Quantity
- 70
- Distribution
- US Nationwide distribution in the states of AL, AZ, CO, FL, GA, KS, KY, LA, MA, MD, MS, NE, NH, NV, NY, OH, TN, WI, WY.
- Recall date
- February 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)