SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws — Class II medical device recall Z-1572-2022
Completed recall by SAFE ORTHOPAEDICS LLC, reported 2022-08-31. The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw
| Recall number | Z-1572-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | SAFE ORTHOPAEDICS LLC, Chicago, IL, United States |
| Recall initiated | 2022-06-03 |
| Classified | 2022-08-24 |
| Reported by FDA | 2022-08-31 |
| Quantity | 8 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 03760219910053, 03760219910060, 03760219910091 |
| Lot numbers | 15BF001/R10, BF0A07, BG0A02, BL0A01 |
| Model numbers | KITM640, KITM645, KITM740 |
Product
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Reason for recall
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.
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-1572-2022. 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.