Orthex Large Bone Shoulder Bolt recall
Orthex Large Bone Shoulder Bolt, model no. AS-17
Why was Orthex Large Bone Shoulder Bolt recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E
- Product
- Orthex Large Bone Shoulder Bolt, model no. AS-17
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 1354 (594 US)
- Distribution
- Domestic distribution to Foreign distribution to
- Recall date
- February 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)