FDA Device recall Z-1133-2023
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
- FDA Device
- Class II
- ongoing
- Published 2023-02-22
On 2023-02-22 the FDA classified a Class II recall of iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE by Conformis, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1133-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-14 |
| Published | 2023-02-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Conformis |
| Distribution | US |
Product
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
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.
Identifiers
| code_info | UDI-DI 00810933030582 Lot D221301 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1133-2023%22
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