Quick Facts at a Glance
- Recall Date
- September 26, 2025
- Hazard Level
- HIGH
- Brand
- Synthes
- 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
- Product type
- Locking Screw for Intramedullary Nail
- Model numbers
- Product Code: 04.045.342TS, GTIN: 10886982301390, Lot Number: 31756P9, Expiration Date: 08/31/2025
- 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
These locking screws are used with intramedullary nail systems to secure implants in long bones. They are supplied in various lengths and require precise labeling to guide surgical use.
Why This Is Dangerous
Packaging length labeling errors may lead to incorrect screw length selection during surgery, potentially compromising fixation.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The mislabeling could require additional surgeries or revisions if incorrect screws are implanted due to length confusion.
Practical Guidance
How to identify if yours is affected
- 1. Locate Product Code 04.045.342TS on packaging.
- 2. Verify Lot Number 31756P9 and Expiration Date 08/31/2025.
- 3. Compare etched screw length with packaging label (42mm vs 46mm).
- 4. If mismatch or uncertain, stop using and contact Synthes.
Where to find product info
Official recall notices and the FDA enforcement page linked in the recall notice.
What timeline to expect
Remediation timelines vary; expect several weeks for replacements or refunds as directed by Synthes.
If the manufacturer is unresponsive
- Document all communications with healthcare providers and Synthes.
- Escalate to hospital procurement if needed.
- Consider filing a complaint with the CPSC if the company is slow to respond.
How to prevent similar issues
- Verify packaging labels before implantation.
- Cross-check label with etched screw length on each device.
- Establish a secondary check with the hospital's supply chain for device labeling accuracy.
Documentation advice
Keep the recall notice, packaging images, lot numbers, and all correspondence with the manufacturer and procurement.
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Product Details
Product Code: 04.045.342TS. GTIN: 10886982301390. Lot Number: 31756P9. Expiration Date: 08/31/2025. System: RFN-Advanced Retrograde Femoral Nailing (RFNA) System and Tibial Nail Advanced System. Quantity: 122 units. Distribution: Worldwide, including US states 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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: 122 units
- Product Code: 04.045.342TS
- Lot Number: 31756P9
- Packaging labeling error: 42mm vs 46mm lengths
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Safety Guide
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