Orthex External Fixation Wire Sharp Bayonet 1 — Class II medical device recall Z-1678-2022
Ongoing recall by OrthoPediatrics Corp, reported 2022-09-14, distributed nationwide. Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The frac
| Recall number | Z-1678-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2022-06-29 |
| Classified | 2022-09-06 |
| Reported by FDA | 2022-09-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 640 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00841132179468 |
| Lot numbers | 238997-B, 239006-B |
| Model numbers | K400-18BN |
Product
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1678-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.