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

Recall date

June 29, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1678-2022

FDA classification

Class II

Brand / firm

OrthoPediatrics Corp

Sold / distributed

US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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