OrthoPediatrics recalls Orthex Large Bone Shoulder Bolt model AS-17 due to potential bolt breakage causing loss of deformity correction and bone regeneration disruption. Affected units include specific lots.
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.
OrthoPediatrics is recalling Orthex Large Bone Shoulder Bolt model AS-17 because it can break, leading to loss of bone alignment and disrupted healing. This affects patients using the device for bone repair.
The bolt can break on the head or threaded part, which may cause the device to no longer hold bones in the correct position. This could disrupt the bone healing process and lead to improper alignment.
Patients using Orthex Large Bone Shoulder Bolt model AS-17 for bone repair are most at risk. The recall applies to specific production lots.
Check for the model number AS-17 on the device. Affected units include specific production lots: 921052140-E through 922038591-E.
Look for the model number AS-17 on the device to confirm if it is affected.
The Orthex Large Bone Shoulder Bolt model AS-17 can break, which may cause loss of deformity correction and disruption of bone regeneration.
The recall does not specify a remedy, so check the product model and lot numbers to see if it is affected.
Affected lots include 921052140-E through 922038591-E.
We’ve drafted a message you can send OrthoPediatrics to request your refund or repair — edit it as you like.
Subject: Recall Z-0277-2023 — OrthoPediatrics OrthoPediatrics Hello, I own a OrthoPediatrics that is covered by recall Z-0277-2023 from OrthoPediatrics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
