Recall Z-0277-2023 ยท OSN Software For Diagnosis/Treatment
OrthoPediatrics Corp
Orthex Large Bone Shoulder Bolt, model no. AS-17
| Date | Nov 22, 2022 (initiated Sep 12, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 j |
| Quantity | 1354 (594 US) |
| Distribution | Domestic distribution to Foreign distribution to |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151881 | X-Fix Line Additions Vilex IN Tennessee, Inc., Mar 24, 2016 |