FDA-Device2023-02-22Class II
Orthex Large Bone Shoulder Bolt, model no. AS-17
OrthoPediatrics Corp
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.
Sold states
Domestic distribution to Foreign distribution to
Affected count
1354 (594 US)
Manufactured in
2850 Frontier Dr, N/A, Warsaw, IN, United States
Products
Orthex Large Bone Shoulder Bolt, model no. AS-17
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0277-2023Don't want to check this manually?
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