Class II — OrthoPediatrics Corp
| Recalling firm | ORTHOPEDIATRICS, CORP |
|---|---|
| Registered facility | ORTHOPEDIATRICS, CORP (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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 |
| Product | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN |
| Quantity | 640 units |
| Distribution | US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia |
| Initiated | 2022-06-29 |
| Classified | 2022-09-06 |
| Recall number | Z-1678-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — OrthoPediatrics Corp (Z-1678-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90738/
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