iTotal Identity Impactor Handle — Class II medical device recall Z-1133-2023
Ongoing recall by Conformis, Inc., reported 2023-02-22, distributed nationwide. Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absenc
| Recall number | Z-1133-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2022-11-14 |
| Classified | 2023-02-13 |
| Reported by FDA | 2023-02-22 |
| Distributed | Nationwide (US) |
| Quantity | 70 |
| UPC / GTIN / UDI-DI | 00810933030582 |
| Lot numbers | D221301 |
| Model numbers | 1080-212/ED-07827REV |
Product
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1133-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.