Z-0277-2023 Class II Ongoing
FDA device recall Z-0277-2023 was initiated by OrthoPediatrics Corp on September 12, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1354 (594 US).
Recall Details
- Product Type
- Devices
- Report Date
- February 22, 2023
- Initiation Date
- September 12, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1354 (594 US)
Product Description
Orthex Large Bone Shoulder Bolt, model no. AS-17
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 Pattern
Domestic distribution to Foreign distribution to
Code Information
UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E