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OrthoPediatrics Corp recalls Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Recalled September 14, 2022 · FDA recall Z-1678-2022 · OrthoPediatrics
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 · FDA Class II
Units
640 units
Sold at
US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
Description
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
Product
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Manufacturer(s)
OrthoPediatrics Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →