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U.S. Department of Health and Human Services

Class 2 Device Recall iTotal Identity Impactor Handle

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  Class 2 Device Recall iTotal Identity Impactor Handle see related information
Date Initiated by Firm November 14, 2022
Date Posted February 13, 2023
Recall Status1 Open3, Classified
Recall Number Z-1133-2023
Recall Event ID 91376
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive - Product Code OIY
Product iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Code Information UDI-DI 00810933030582 Lot D221301
Recalling Firm/
Manufacturer		 Conformis, Inc.
600 Technology Park Dr Ste 3
Billerica MA 01821-4154
For Additional Information Contact Denise Pedulla
781-345-9001
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action On November 14, 2022, the firm sent an Instrument care reminder to field reps, which included an Instrument handling and care reminder. The firm sent additional letters and emails to affected consignees starting January 17, 2023. Consignees were instructed to inspect their inventory for product from the affected lot. Immediately cease use of affected product and contact customer service if a field representative has not already reached out to you. Conformis will have a field representative come onsite to inspect, apply Loctite, and review techniques for inspecting the instrument. Customers were informed they may continue to use impactor handles from other lots. However, they should ensure they are properly connecting the impactor handle to the keel punch (Refer to surgical technique guide).
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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