FDA recall Z-1678-2022

OrthoPediatrics Corp · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2022-06-29
Report date
2022-09-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1678-2022