OrthoPediatrics Corp: Medical Device Recall in 2022 - (Recall #: Z-1678-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 29, 2022

Date Posted: September 14, 2022

Recall Number: Z-1678-2022

Event ID: 90738

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

Status: Ongoing

Product Quantity: 640 units

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

Voluntary or Mandated:

Voluntary: Firm initiated