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Encore Medical, Lp recalls djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or frac
Recalled August 15, 2012 · FDA recall Z-2146-2012 · Encore Medical
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. · FDA Class II
Units
18 devices
Sold at
Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
Description
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.
Product
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →