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Synthes, Inc.

34 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA recall (Z-2092-2015)Synthes, Inc.2015-07-16
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Sy recall (Z-2051-2015)Synthes, Inc.2015-07-08
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, recall (Z-1915-2015)Synthes, Inc.2015-06-26
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with q recall (Z-1799-2015)Synthes, Inc.2015-06-15
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Scre recall (Z-1800-2015)Synthes, Inc.2015-06-15
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulat recall (Z-1711-2015)Synthes, Inc.2015-06-04
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthope recall (Z-1600-2015)Synthes, Inc.2015-05-12
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 recall (Z-1352-2015)Synthes, Inc.2015-03-30
Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for s recall (Z-1313-2015)Synthes, Inc.2015-03-23
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (p recall (Z-1281-2015)Synthes, Inc.2015-03-16
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) recall (Z-1260-2015)Synthes, Inc.2015-03-10
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the cont recall (Z-1094-2015)Synthes, Inc.2015-02-11
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used recall (Z-1021-2015)Synthes, Inc.2015-01-28
The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305 recall (Z-1009-2015)Synthes, Inc.2015-01-23
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissue recall (Z-0973-2015)Synthes, Inc.2015-01-14
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended recall (Z-0219-2015)Synthes, Inc.2014-11-14
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715 recall (Z-0092-2015)Synthes, Inc.2014-10-20
DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 33376 recall (Z-2674-2014)Synthes, Inc.2014-09-22
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distract recall (Z-2148-2014)Synthes, Inc.2014-08-20
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set recall (Z-2265-2014)Synthes, Inc.2014-08-19
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) recall (Z-2087-2014)Synthes, Inc.2014-07-21
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part num recall (Z-1984-2014)Synthes, Inc.2014-07-02
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance c recall (Z-1833-2014)Synthes, Inc.2014-06-19
Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cut recall (Z-1781-2014)Synthes, Inc.2014-06-11
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL Sys recall (Z-1681-2014)Synthes, Inc.2014-06-02
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling recall (Z-1669-2014)Synthes, Inc.2014-05-29
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expo recall (Z-1457-2014)Synthes, Inc.2014-04-15
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialf recall (Z-1456-2014)Synthes, Inc.2014-04-14
Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of f recall (Z-1274-2014)Synthes, Inc.2014-03-25
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch T recall (Z-1174-2014)Synthes, Inc.2014-03-11
Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Com recall (Z-1125-2014)Synthes, Inc.2014-03-04
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and recall (Z-1057-2014)Synthes, Inc.2014-02-20
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surger recall (Z-0992-2014)Synthes, Inc.2014-02-19
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw recall (Z-0986-2014)Synthes, Inc.2014-02-16

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Every clearance here is in the API, with alerts when new ones post.