Synthes 3.0mm Headless Compression Screw Recall: Incorrect Thread Length
Synthes recalls 3.0mm headless compression screws with incorrect thread length (4mm instead of 6mm) that may not fit properly in medical implants.
Lower-risk recall
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
Contact the company
What happened, in plain English
Synthes is recalling 3.0mm headless compression screws that were labeled as having a 6mm thread but actually have a 4mm thread. This mismatch could cause improper fixation in medical procedures, potentially leading to complications. Read more at govinfonow.com/recall/69870-synthes-3-0mm-headless-compression-screw-recall-incorrect-thread-length.
Source Summary by GovInfoNow · govinfonow.com/recall/69870-synthes-3-0mm-headless-compression-screw-recall-incorrect-thread-length · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0238-2019
Cite this page
“Synthes 3.0mm Headless Compression Screw Recall: Incorrect Thread Length.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69870-synthes-3-0mm-headless-compression-screw-recall-incorrect-thread-length. Based on FDA recall #Z-0238-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0238-2019%22&limit=1).
Why it’s dangerous
The screws have a shorter thread length (4mm) than labeled (6mm), which could cause them to not engage properly with bone. This might lead to loosening or failure of the implant during healing.
Who’s affected
Orthopedic surgeons and medical professionals who use these screws for bone fixation are most at risk. Patients receiving these screws during surgery may experience improper healing.
How to tell if you have this one
Check for part number 04.226.118 on the screw package. The screws were sold with lot number L734474. They are used in orthopedic procedures for small bone fractures.
- Brand
Synthes- Category
Medical device
What to do — step by step
Check Product Label
Verify the thread length on the screw package; labeled as 6mm but actual thread length is 4mm.
Where it went and when
Where it was distributed
Distributed in 7 states.
FDA distribution: “US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Arkansas, Florida, Illinois, New Mexico, Ohio, Texas.
Recall timeline
FDA terminated this recall 19 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.
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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-0238-2019 (September 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0238-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.