03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair [Code Info] Lot 007A1037, Ref 010-55-25. [Reason for Recall] 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. [Recalling Firm] Encore Medical, Lp [Classification] 
Class II
C l a s s I I
C l a s s I I I
C l a s s I
Enforcement Report - Week of August 15, 2012