Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Check against the official notice below — it lists the full affected range.
OrthoPediatrics Corp has recalled Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm (Model K400-18BN) due to a manufacturing variance near the wire tip that increases the likelihood of the tip fracturing. If the tip fractures, it may remain in the patient's body, and attempts to retrieve it could delay surgery and potentially damage soft tissue, increasing healing time. The recall affects 640 units distributed nationwide across Arizona, Alabama, California, Florida, Maryland, Missouri, North Carolina, New York, and Texas, as well as Australia.
The affected product has UDI 00841132179468 and lot numbers 239006-B and 238997-B. The recall notice does not specify a remedy or recommended action for consumers who may have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Quantity: 640 units Lot/code info: UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.