Class II — SAFE ORTHOPAEDICS LLC
| Recalling firm | Safe Orthopaedics |
|---|---|
| Registered facility | SAFE ORTHOPAEDICS SAS (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct. |
| Product | SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740. |
| Quantity | 8 devices |
| Distribution | Distribution was made to MD. There was no government/military distribution. |
| Initiated | 2022-06-03 |
| Classified | 2022-08-24 |
| Recall number | Z-1572-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SAFE ORTHOPAEDICS LLC (Z-1572-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90542/
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