Orthex Large Bone Shoulder Bolt — Class II medical device recall Z-0277-2023
Ongoing recall by OrthoPediatrics Corp, reported 2023-02-22. Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may c
| Recall number | Z-0277-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2022-09-12 |
| Classified | 2023-02-10 |
| Reported by FDA | 2023-02-22 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00841132143155 |
| Lot numbers | 921052140-E, 922000760-E, 922023360-E, 922023370-E, 922038571-E, 922038581-E, 922038591-E |
| Model numbers | AS-17 |
Product
Orthex Large Bone Shoulder Bolt, model no. AS-17
Reason for recall
Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
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-0277-2023. 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.