FDA recall Z-0277-2023

Product

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

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

Key facts

Status

Ongoing

Initiation date

2022-09-12

Report date

2023-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0277-2023