Orthex Large Bone Shoulder Bolt, model no. AS-17
Recall
- Recall Number
- Z-0277-2023
- Event Number
- 91098
- Firm
- OrthoPediatrics Corp
- FEI Number
- 3006460162
- Product Code
- OSN
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- September 12, 2022
- Posted
- November 22, 2022
- Address
- 2850 Frontier Dr, Warsaw, IN, 46582-7001
Description
Orthex Large Bone Shoulder Bolt, model no. AS-17
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.
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 [email protected] or 574-367-5396.
Domestic distribution to Foreign distribution to
1354 (594 US)