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U.S. Department of Health and Human Services

Medical Device Recalls

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Product: cet
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Synvisc-One ® (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous h... 2 02/14/2018 Sanofi Genzyme
PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc®... 2 01/04/2018 Zimmer Biomet, Inc.
Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delt... 2 11/06/2017 Limacorporate S.p.A
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label a... 2 09/12/2017 Beckman Coulter Inc.
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to h... 2 02/11/2017 Mako Surgical Corporation
AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm... 2 01/17/2017 Exactech, Inc.
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-1... 2 01/03/2017 Interventional Spine Inc
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howme... 2 10/07/2016 Stryker Howmedica Osteonics Corp.
00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ... 2 06/10/2016 Zimmer Trabecular Metal Technology, Inc.
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number... 2 06/02/2016 Exactech, Inc.

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