HIGH

Synthes 5.0mm IM Nail Locking Screws Recalled for Packaging Length Label Error (120 Units, 2025)

Synthes (USA) Products LLC recalled 120 low-profile locking screws for intramedullary nails used in the RFN-Advanced Retrograde Femoral Nailing System and the Tibial Nail Advanced System. The recall covers devices distributed worldwide through healthcare providers. The external packaging mislabels screw lengths: 42 mm screws are labeled 46 mm and 46 mm screws are labeled 42 mm. Hospitals and spine

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

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

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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

  1. Confirm the product is the 04.045.346TS screw.
  2. Check the packaging label against the etched length on the screw.
  3. Verify Lot Number 31756P7.
  4. Compare packaging length label to the actual screw length (42 mm vs 46 mm).
  5. 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.

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

  • 120 units recalled
  • Product Code 04.045.346TS
  • GTIN 10886982301413
  • Lot Number 31756P7
  • Expiration 08/31/2025
  • Packaging length mislabeling involves 42 mm vs 46 mm lengths
View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
LACERATIONOTHER

Product Classification

Product TypeLocking screw for intramedullary nail
Sold At
Multiple Retailers

Product Details

Model Numbers
04.045.346TS
Affected States
ALL
Report Date
October 29, 2025
Recall Status
ACTIVE

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