Recall archive / FDA device enforcement
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN — FDA record Z-1678-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 29, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
- 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
- Classification
- Class II
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 640 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1678-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 14, 2022
- Recall initiation date
- Jun 29, 2022
- Center classification date
- Sep 6, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.