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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Product Detail

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
Recall Number Z-2146-2012
Classification Class II
Code Info Lot 007A1037, Ref 010-55-25.
Product Distributed Qty 18 devices
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.

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 Letter
Distribution Pattern Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.
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