Synthes LOW PROF LCKNG SCREW: Incorrect Length Labeling on Packaging
Synthes recalls LOW PROF LCKNG SCREW (Product Code 04.045.346TS) due to incorrect length labeling on packaging. 42mm screws labeled as 46mm and vice versa. No immediate action needed as this is a labeling error, not a safety hazard.
Lower-risk recall
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
Contact the company
What happened, in plain English
Synthes is recalling a specific type of surgical screw due to incorrect length labeling on the packaging. This means some screws labeled as 46mm are actually 42mm, and vice versa. This labeling error does not pose a safety risk but could lead to improper use in medical procedures. Read more at govinfonow.com/recall/51201-synthes-low-prof-lckng-screw-incorrect-length-labeling-on-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/51201-synthes-low-prof-lckng-screw-incorrect-length-labeling-on-packaging · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0228-2026
Cite this page
“Synthes LOW PROF LCKNG SCREW: Incorrect Length Labeling on Packaging.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51201-synthes-low-prof-lckng-screw-incorrect-length-labeling-on-packaging. Based on FDA recall #Z-0228-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0228-2026%22&limit=1).
Why it’s dangerous
The packaging incorrectly labels the screw length. Screws that should be 46mm are labeled as 42mm, and vice versa. This could lead to using the wrong screw size during surgery, potentially causing complications.
Who’s affected
Surgical professionals using the RFN-ADVANCEDTM Retrograde Femoral Nailing system or Tibial Nail Advanced System with the specific product code 04.045.346TS are affected. Patients receiving these screws during surgery may be at risk if the incorrect screw size is used.
How to tell if you have this one
Check the product code on the packaging: 04.045.346TS. Look for the screw size labeled as 42mm or 46mm on the packaging. The screws are used in RFN-ADVANCEDTM systems and have an expiration date of August 31, 2025.
- Brand
Synthes- Product
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM- 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 AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0228-2026 | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.; Product Code: 04.045.346TS. GTIN: 10886982301413. Lot Number: 31756P7. Expiration Date: 08/31/2025 | 120 units |
| Z-0229-2026 | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.; Product Code: 04.045.342TS. GTIN: 10886982301390. Lot Number: 31756P9. Expiration Date: 08/31/2025 | 122 units |
What to do — step by step
Verify Product Code
Check the product code on the packaging to confirm it is 04.045.346TS.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 23 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, New Mexico, New York, Ohio, Tennessee, Texas.
Recall timeline
FDA published this recall 33 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.
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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-0228-2026 (September 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0228-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.