Summary
The FDA issued a Class II for iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE by Conformis, Inc.. Reason: 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 fal.
Details
Source
Device Recall
External ID
Z-1133-2023
Action Date
2023-02-22
Status
Ongoing
Category
device
Product Description
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Lot/Code Info: UDI-DI 00810933030582 Lot D221301
Quantity Affected: 70
Reason for Recall
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-14
Company
Billerica, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Conformis, Inc. has 16 FDA actions in our database, including 5 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Conformis, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Conformis, Inc. have FDA actions?
Conformis, Inc. has 16 FDA actions in our database, including 5 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1133-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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