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OrthoPediatrics Corp Recall 90738

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

OrthoPediatrics Corp Recall 90738 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1678-2022
Event ID90738
Event DescriptionOrthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Product TypeDevices
DistributionUS Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
Quantity640 units
Recall ReasonManufacturing 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
Device Classification20220914
Device Code InfoUDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
Center Classification Date20220906
Recall Initiation Date20220629
Recalling FirmOrthoPediatrics Corp
Initial Notification Visit
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