FDAFDA · Food and drugs·Recall number Z-1132-2013
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
Published April 24, 2013 · Recall initiated: March 6, 2013
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
One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Smith & Nephew Inc
- Distributor
- Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
- Lot
- Lot Number 12FM12182
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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