FDA-Device2012-08-15Class II
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Encore Medical, Lp
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.
Sold states
Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
Affected count
18 devices
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2146-2012Don't want to check this manually?
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