Quick Facts at a Glance
- Recall Date
- February 25, 2026
- 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
- Bone tap (Orthopedic surgical instrument)
- Model numbers
- 03.424.126-US, 03.424.124-US, 68982P8, 68900P9
- Sold at
- Multiple Retailers
- 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
Orthopedic bone taps used to prepare bone threads for screws during surgery, part of orthopedic instrumentation.
Why This Is Dangerous
A lot swap caused taps with incorrect thread, risking improper fixation during implantation during orthopedic procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
For patients, this recall introduces risk during orthopedic procedures and may affect implant stability; no injuries reported.
Practical Guidance
How to identify if yours is affected
- Check lot numbers: 68982P8 or 68900P9.
- Verify packaging label and GTIN if provided.
- If affected, stop use and contact manufacturer.
Where to find product info
Lot numbers and model on device label and packaging. GTIN on packaging.
What timeline to expect
Recall notifications by letter; replacement or remediation timelines to be determined by manufacturer.
If the manufacturer is unresponsive
- Escalate to FDA recall contact
- File a consumer complaint with FDA if needed
- Seek assistance from your healthcare provider
How to prevent similar issues
- Implement strict lot-control and traceability for surgical instruments.
- Verify lot numbers before use.
- Establish clear communication channels between hospitals and suppliers.
Documentation advice
Keep recall notices, packaging, and all correspondence; document dates and contacts.
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Product Details
Model numbers: 03.424.126-US; 03.424.124-US. GTIN: 10886982335951. Lot numbers: 68982P8, 68900P9. Where sold: Nationwide US distribution in AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI. Sold since unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot 68982P8 and Lot 68900P9
- Nationwide distribution in AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT,VA
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Safety Guide
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