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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 62561
Product Type Devices
Status Ongoing
Recalling Firm Encore Medical, Lp
City Austin
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-16
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair Lot 007A1037, Ref 010-55-25. Class II 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. 18 devices Z-2146-2012