Orthex recallZ-1678-2022 · OrthoPediatrics Corp · initiated Jun 29, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OrthoPediatrics Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Process change control
What the company is doing
OrthoPediatrics Corp. provided Urgent Medical Device recall Letter to Distributors on 6/29/22. Letter states reason for recall, health risk and action to take: The affected product must be returned to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. Distributors should retrieve affected product that may be with customers. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response acknowledgement form confirming your understanding of these instructions. Any questions regarding this recall can be directed to Joel Batts, Senior VP of Science & Technology, at OrthoPediatrics at [email protected] or 574-367-5396.
Recall details
- Recall number
- Z-1678-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 29, 2022
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 640 units
- Product code
- KTT
- FDA submissions
- K151881
- Distribution
- US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
Product description
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Code information (models, lots, serial numbers)
UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Orthex K400-18BNOrthopediatrics Corp. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page