Recall archive / FDA device enforcement
Orthex Large Bone Shoulder Bolt, model no. AS-17 — FDA record Z-0277-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 12, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 1354 (594 US)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0277-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to Foreign distribution to
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Feb 22, 2023
- Recall initiation date
- Sep 12, 2022
- Center classification date
- Feb 10, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.