FDA-Device2022-09-14Class II
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
OrthoPediatrics Corp
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
Sold states
US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
Affected count
640 units
Manufactured in
2850 Frontier Dr, N/A, Warsaw, IN, United States
Products
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1678-2022Don't want to check this manually?
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