Osteomed 1.6mm x 4mm Profile Zero Auto-Drive Screw Recall: Risk of Screw Passing Through
Osteomed recalls sterile surgical screws with a potential risk of the screw passing through the plate hole during osteotomies. Affected units include specific lot numbers and model designations.
Use caution until it’s fixed
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Contact the company
What happened, in plain English
Osteomed is recalling sterile surgical screws that may have an undersized screwhead, which could pass through the plate hole during osteotomies. This poses a risk of improper fixation and potential complications for patients. Read more at govinfonow.com/recall/57923-osteomed-1-6mm-x-4mm-profile-zero-auto-drive-screw.
Source Summary by GovInfoNow · govinfonow.com/recall/57923-osteomed-1-6mm-x-4mm-profile-zero-auto-drive-screw · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2107-2023
Cite this page
“Osteomed 1.6mm x 4mm Profile Zero Auto-Drive Screw Recall: Risk of Screw Passing Through.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57923-osteomed-1-6mm-x-4mm-profile-zero-auto-drive-screw. Based on FDA recall #Z-2107-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2107-2023%22&limit=1).
Why it’s dangerous
The screws have an undersized screwhead that can pass through the plate hole during osteotomy procedures. This may lead to improper fixation of bone fragments and potential complications such as misalignment or infection.
Who’s affected
Surgical patients and healthcare providers who use these specific screws for osteotomies. Patients with the recalled lot numbers are most at risk.
How to tell if you have this one
Check for the model: 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile. Lot numbers 1177027, 1177718, or 1177812 are affected. These were sold with UDI-DI: (01)00845694034258.
- Brand
Osteomed- Product
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG.
| Recall number | Product, codes & lots |
|---|---|
| Z-2107-2023 | REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile; Lot # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258 |
| Z-2108-2023 | REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile; Lot # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006 |
What to do — step by step
Check Product Details
Verify the lot number and model designation to confirm if your screw is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 13 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Kansas, Kentucky, Maryland, Missouri, Montana, Nebraska, New York, Tennessee, Texas.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are there any immediate risks to patients using these screws?
The recall is for potential improper fixation during osteotomies, but no specific injuries have been reported. Patients should follow the manufacturer's guidance.
Similar recalls
Latest medical device recalls
Keep exploring
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-2107-2023 (May 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2107-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 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.