OrthoPediatrics Corp Recall 90738
Description: Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
OrthoPediatrics Corp Recall 90738 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1678-2022 |
| Event ID | 90738 |
| Event Description | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN |
| Product Type | Devices |
| Distribution | US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia |
| Quantity | 640 units |
| Recall Reason | Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time |
| Device Classification | 20220914 |
| Device Code Info | UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B |
| Center Classification Date | 20220906 |
| Recall Initiation Date | 20220629 |
| Recalling Firm | OrthoPediatrics Corp |
| Initial Notification | Visit |
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