Quick Facts at a Glance
- Recall Date
- September 26, 2025
- Hazard Level
- HIGH
- Brands
- Synthes, Synthes (USA)
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Synthes, Synthes (USA)
- Product type
- Locking screw for intramedullary nail
- Model numbers
- 04.045.346TS
- Sizes
- 42 mm, 46 mm
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 26, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Synthes (USA) Products LLC or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
This product is a low-profile locking screw used with intramedullary nail systems for orthopedic procedures, including retrograde femoral and tibial nailing. Surgeons rely on precise screw lengths for stable fixation.
Why This Is Dangerous
The external packaging mislabels screw lengths, which could lead to selecting the incorrect screw length during surgery. The etched screw length on the device itself is correct.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The discrepancy could affect surgical planning and implant fit. The recall involves 120 units distributed worldwide. No injuries or incidents are reported in the available data.
Practical Guidance
How to identify if yours is affected
- Confirm the product is the 04.045.346TS screw.
- Check the packaging label against the etched length on the screw.
- Verify Lot Number 31756P7.
- Compare packaging length label to the actual screw length (42 mm vs 46 mm).
- If label and screw length do not match, set aside and follow recall instructions.
Where to find product info
Look for Product Code 04.045.346TS, GTIN 10886982301413, Lot 31756P7, Expiration 08/31/2025 on the packaging.
What timeline to expect
Recall timeline and replacement process are not specified. Follow instructions from Synthes and the healthcare facility.
If the manufacturer is unresponsive
- Document all communications with Synthes or suppliers.
- Escalate to the hospital's risk management office or recall coordinator.
- Consult the FDA recall page if needed for additional guidance.
How to prevent similar issues
- Implement a verification step for implant lengths before packaging in facilities.
- Train surgical staff to cross-check etched screw length with packaging label.
- Request replacement labeling or tamper-evident packaging when ordering implants in the future.
Documentation advice
Keep the recall notice, photos of affected packaging, Product Code, GTIN, Lot Number, and all correspondence with the manufacturer.
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Product Details
Model numbers and identifiers: Product Code 04.045.346TS. GTIN 10886982301413. Lot Number 31756P7. Expiration Date 08/31/2025. Quantity recalled: 120 units. Distribution: Worldwide with US distribution in AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and Canada. Sold through healthcare providers. Manufacturer: Synthes (USA) Products LLC.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Code 04.045.346TS
- Lot Number 31756P7
- Packaging length mislabeling involves 42 mm vs 46 mm lengths
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Safety Guide
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