OrthoPediatrics Recalls 7.0mm Pedicle Screws Due to Color Anodizing Error
OrthoPediatrics recalls 7.0mm x 40mm pedicle screws for posterior non-cervical spine fixation due to color anodizing error with smaller screws. Affected units have model 00-1300-0: M82791-1 lot.
Lower-risk recall
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Contact the company
What happened, in plain English
OrthoPediatrics is recalling 7.0mm x :40mm pedicle screws used in spine surgery for posterior non-cervical areas because they were color anodized with the same color as smaller screws. This could cause confusion during surgical procedures. Read more at govinfonow.com/recall/73256-orthopediatrics-recalls-7-0mm-pedicle-screws-due-to-color-anodizing.
Source Summary by GovInfoNow · govinfonow.com/recall/73256-orthopediatrics-recalls-7-0mm-pedicle-screws-due-to-color-anodizing · Updated September 19, 2026 · FDA enforcement record: FDA #Z-0597-2018
Cite this page
“OrthoPediatrics Recalls 7.0mm Pedicle Screws Due to Color Anodizing Error.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73256-orthopediatrics-recalls-7-0mm-pedicle-screws-due-to-color-anodizing. Based on FDA recall #Z-0597-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0597-2018%22&limit=1).
Why it’s dangerous
The screws have been color anodized with the same color as 5mm diameter screws. This visual similarity could lead to using the wrong screw size during spinal surgery, potentially causing complications.
Who’s affected
Surgical teams using these screws for spine procedures are affected. Patients undergoing spinal surgery with this specific screw model are at risk of using the wrong size during surgery.
How to tell if you have this one
Check for model number 00-1300-0740 and lot number M82791-1 on the packaging. These screws are used in posterior non-cervical spine fixation procedures.
- Brand
OrthoPediatrics- Category
Medical device
What to do — step by step
Check Product Details
Verify the model number (00-1300-0740) and lot number (M82791-1) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall is for potential confusion during surgery, not a direct risk of injury. This is considered low risk.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0597-2018 (August 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0597-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.