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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 11 Results
510(K) Number: K090234
 
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Product Description
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Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7... 2 02/05/2020 Implant Direct Sybron Manufacturing LLC
Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 2 02/04/2020 Implant Direct Sybron Manufacturing LLC
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, ... 2 11/12/2019 Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx,... 2 10/01/2019 Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect c... 2 05/23/2018 Implant Direct Sybron Manufacturing, LLC
SwishTapered Implant Intended for use in support for fixed bridgework. 2 03/22/2018 Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implan... 2 11/29/2017 Implant Direct Sybron Manufacturing, LLC
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Denta... 2 10/03/2017 Implant Direct Sybron Manufacturing, LLC
SwishTapered Implant 2 01/28/2017 Implant Direct Sybron Manufacturing, LLC
GoDirect Screw-Retaining Top Part Numbers: 4500-61 2 01/09/2017 Implant Direct Sybron Manufacturing, LLC
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