Orthex Large Bone Shoulder Bolt, model no. AS-17
- Company
- Orthopediatrics Corp
- Recall Initiated
- September 12, 2022
- Posted
- November 22, 2022
- Recall Number
- Z-0277-2023
- Quantity
- 1354 (594 US)
- Firm Location
- Warsaw, IN
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
Lot / Code Info
UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E
Root Cause
Under Investigation by firm
Action Taken
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.