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FDAJune 29, 2022device

Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

orthopediatrics

UPCs

00841132179468

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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