OrthoPediatrics Corp Orthex Large Bone Shoulder Bolt, model no. AS-17 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Orthex Large Bone Shoulder Bolt, model no. AS-17
Brand
OrthoPediatrics Corp
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E
OrthoPediatrics Corp is recalling Orthex Large Bone Shoulder Bolt, model no. AS-17 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On September 12, 2022, the firm notified distributors of the recall. Distributors were asked to notify and retrieve affected devices from end users. Affected product must be returned to OrthoPediatrics. Replacement product will be provided. Customers should contact customer service to arrange return of the affected product. Customers who have patients in frames should be made aware of the possibility of Bolt breakage and continue monitoring their patients. Any questions regarding this recall can be directed to Joel Batts, Senior VP of Clinical and Regulatory Affairs, at OrthoPediatrics at jbatts@orthopediatrics.com or 574-367-5396.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026