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Recall Observatory FDA recall evidence

Device product

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

Z-0277-2023

September 12, 2022

Class II

Product summary

Firm
OrthoPediatrics Corp
Event
Event 91098
Status
Ongoing
Classification
Class II
Quantity
1354 (594 US)
Official record key
device-enforcement:Z-0277-2023

Official wording

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.

Code information: UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E

Distribution pattern: Domestic distribution to Foreign distribution to

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.