OrthoPediatrics Corp: Orthex Large Bone Shoulder Bolt, model no. AS-17

Hazard

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.

Details from the source

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. Distribution: Domestic distribution to Foreign distribution to Quantity: 1354 (594 US) Lot/code info: UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E

UPC codes

00841132143155

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.