HIGH

Synthes 5.0mm IM Nail Screw Recalled for Labeling Error (2025)

Synthes USA recalled 122 locking intramedullary nail screws used in RFN-Advanced and Tibial Nail Advanced systems. The recall covers worldwide distribution including the US and Canada. The packaging labeling misstates screw length while the etched length on the screw is correct. Healthcare providers should stop using the device immediately and follow recall instructions from Synthes.

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

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

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. 1. Locate Product Code 04.045.342TS on packaging.
  2. 2. Verify Lot Number 31756P9 and Expiration Date 08/31/2025.
  3. 3. Compare etched screw length with packaging label (42mm vs 46mm).
  4. 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.

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
  • GTIN: 10886982301390
  • Lot Number: 31756P9
  • Expiration Date: 08/31/2025
  • Packaging labeling error: 42mm vs 46mm lengths
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
5/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeLocking Screw for Intramedullary Nail
Sold At
Multiple Retailers

Product Details

Brand
Synthes
Model Numbers
Product Code: 04.045.342TS
GTIN: 10886982301390
Lot Number: 31756P9
Expiration Date: 08/31/2025
Affected States
ALL
Report Date
October 29, 2025
Recall Status
ACTIVE

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