OrthoPediatrics Corp: Medical Device Recall in 2023 - (Recall #: Z-0277-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 12, 2022

Date Posted: February 22, 2023

Recall Number: Z-0277-2023

Event ID: 91098

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.

Status: Ongoing

Product Quantity: 1354 (594 US)

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

Voluntary or Mandated:

Voluntary: Firm initiated