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U.S. Department of Health and Human Services

Medical Device Recalls

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Date Classified to: 05/08/2014 PMA Number: P110013/S005
 
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Solanas 2.1mm FIXED DEPTH DRILL, 10mm , Part No. 63928-10 The SOLANAS III Posterior Stabilization... 2 Jul-22-2014 Alphatec Spine, Inc.
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE® Redi-Code+... 1 Jul-22-2014 DIABETIC SUPPLY OF SUNCOAST, INC.
MK5 NX Controller--Wheelchair controller 2 Jul-22-2014 Invacare Corporation
LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest ... 3 Jul-22-2014 Zoll Circulation, Inc.
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create... 2 Jul-22-2014 Perouse Medical
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 ... 2 Jul-21-2014 Exactech, Inc.
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing ... 2 Jul-21-2014 AGFA Corp.
RECLAIM® DISTAL TAPERED, Angled Distal Stem, various sizes, To ensure the locking taper surface ... 2 Jul-21-2014 DePuy Orthopaedics, Inc.
RECLAIM® DISTAL TAPERED Distal Stem, various sizes, To ensure the locking taper surface of the D... 2 Jul-21-2014 DePuy Orthopaedics, Inc.
RECLAIM® TAPER PROTECTOR SLEEVE To ensure the locking taper surface of the Distal Stem is protect... 2 Jul-21-2014 DePuy Orthopaedics, Inc.

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