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
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 Tap for Bone Taps
- Model numbers
- Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 25, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify Part Number 03.424.124-US on the device label.
- Check Lot Number 68900P9.
- 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.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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
- 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
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.