FDAFDA · Food and drugs·Recall number Z-2146-2012
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Published August 15, 2012 · Recall initiated: July 16, 2012
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 lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
- Lot
- Lot 007A1037, Ref 010-55-25.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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