Recall Z-1133-2023 ยท OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Conformis, Inc.
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
| Date | Feb 13, 2023 (initiated Nov 14, 2022) |
| Status | Open, Classified |
| 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 fall into the patient during a procedure. |
| Root cause | 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 w |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.