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Recall Observatory FDA recall evidence

Device product

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

Z-1678-2022

June 29, 2022

Class II

Product summary

Firm
OrthoPediatrics Corp
Event
Event 90738
Status
Ongoing
Classification
Class II
Quantity
640 units
Official record key
device-enforcement:Z-1678-2022

Official wording

Reason: 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

Code information: UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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