FDA Device recall Z-0277-2023
Orthex Large Bone Shoulder Bolt, model no
- FDA Device
- Class II
- ongoing
- Published 2023-02-22
On 2023-02-22 the FDA classified a Class II recall of Orthex Large Bone Shoulder Bolt, model no by Orthopediatrics, citing 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 regenerat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0277-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-12 |
| Published | 2023-02-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Orthopediatrics |
| Distribution | n/a |
Product
Orthex Large Bone Shoulder Bolt, model no. AS-17
Reason
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.
Identifiers
| code_info | UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2019-11-06 · Orthopediatrics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0277-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.