HIGH

Synthes 2.4V Bone Tap Locking Screw Tap 90mm Recall for 77 Units Nationwide (2026)

Synthes recalls 77 bone taps nationwide after a lot swap created an incorrect thread. The recall covers the 2.4 volt locking screw tap to 90mm, part number 03.424.124-US. Healthcare providers and facilities should stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
February 25, 2026
Hazard Level
HIGH
Brand
Synthes
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PETS, PREGNANT

Hazard Information

A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

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: Letter

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About This Product

Bone taps are surgical tools used to create threads in bone during orthopedic procedures. The locking screw taps are designed to secure implants.

Why This Is Dangerous

The incorrect thread may prevent proper seating of taps and implants, risking surgical complications.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals and surgeons may need to halt use of the affected inventory and issue replacements, potentially delaying procedures.

Practical Guidance

How to identify if yours is affected

  1. Verify Part Number 03.424.124-US on the device label.
  2. Check Lot Number 68900P9.
  3. Confirm GTIN 10886982335944.
  4. Ensure the device is within the 2.4V bone tap family and 90mm length.

Where to find product info

Labels on the device and packaging, recall notification letters, and the FDA enforcement page.

What timeline to expect

Remedy timelines vary; expect 4-6 weeks for refund or replacement processing after confirmation.

If the manufacturer is unresponsive

  • File a complaint with the CPSC if the company is unresponsive.
  • Escalate with hospital compliance teams or healthcare distributors.

How to prevent similar issues

  • Use only parts with correct lot numbers and part numbers.
  • Source through authorized distributors and verify labeling before use.
  • Maintain an inventory log to segregate recalled lots.
  • Cross-check lot numbers against recall notices before surgeries.

Documentation advice

Keep recall notices, serial and lot data, purchase records, and correspondence with supplier for your records.

Product Details

Model/part: Part Number 03.424.124-US. GTIN 10886982335944. Lot 68900P9. Distribution: US nationwide in AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 77 units recalled
  • Part Number 03.424.124-US; GTIN 10886982335944; Lot 68900P9
  • Distributed across 20 states: AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT
  • Recall date 2026-02-25; status ACTIVE
  • Hazard: incorrect thread due to lot swap
  • Remedy: stop use and follow manufacturer instructions
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

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

Product Classification

Product TypeLocking Screw Tap for Bone Taps
Sold At
Unknown

Product Details

Brand
Synthes
Model Numbers
Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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