FDA recall, , Moderate risk
Synthes 2.4 Volt Tap Locking and Cortex Screws
Bone taps have an incorrect thread due to a lot swap.
Summary by Recall Canary from the FDA notice
What happened
Synthes (USA) Products LLC, of West Chester, Pennsylvania, recalled 2.4 Volt Tap Locking Screw Tap to 90MM and 2.4 Volt(TM) Tap Cortex Screw to 90MM because a full lot swap between the products resulted in the bone taps having an incorrect thread. The recall began on February 25, 2026, and was added to the FDA's Enforcement Report on March 30, 2026.
The products were distributed nationwide in 21 states, including Arkansas, Arizona, California, Colorado, Florida, Indiana, Louisiana, Maryland, Minnesota, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI, lot code and part code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
2.4 VOLT TAP Locking Screw TAP to 90MM.
- UDI-DI
- 10886982335944
- Part code
- 03.424.124-US.
- Lot code
- 68900P9
2.4 VOLT(TM) TAP Cortex Screw to 90MM.
- UDI-DI
- 10886982335951
- Part code
- 03.424.126-US.
- Lot code
- 68982P8
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arkansas, Arizona, California, Colorado, Florida, Indiana, Louisiana, Maryland, Minnesota, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
- Company
- Synthes (USA) Products LLCWest Chester, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98461
- Recall numbers
- Z-1702-2026 to Z-1703-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
