Home / Recalls / Medical Devices
OrthoPediatrics Corp recalls Orthex Large Bone Shoulder Bolt, model no. AS-17
Recalled February 22, 2023 · FDA recall Z-0277-2023 · OrthoPediatrics
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. · FDA Class II
Units
1354 (594 US)
Sold at
Domestic distribution to Foreign distribution to
Description
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.
Product
Orthex Large Bone Shoulder Bolt, model no. AS-17
Manufacturer(s)
OrthoPediatrics Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →