FDA Device recall Z-1678-2022
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
- FDA Device
- Class II
- ongoing
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN by Orthopediatrics, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1678-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-29 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Orthopediatrics |
| Distribution | US |
Product
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
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
Identifiers
| code_info | UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1678-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.