FDAFDA · Food and drugs·Recall number Z-1844-2017
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Published April 26, 2017 · Recall initiated: March 15, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
- Lot
- Batch Numbers: F93301, F93303, G04665, G27840, G27841
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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