Synthes Recalls
43 recalls on record · February 26, 2014 to August 5, 2020 · Medical Devices
Recalls by year
14
15
18
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 9, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026
Hazard: All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.
June 25, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Hazard: Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
June 18, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral,
Hazard: It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.
June 11, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacem
Hazard: Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
June 4, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft
Hazard: Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
April 23, 2014Medical DevicesFDA
Synthes, Inc. recalls The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
Hazard: The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.
April 23, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and
Hazard: The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.
April 2, 2014Medical DevicesFDA
Synthes, Inc. recalls Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonu
Hazard: The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template.
March 19, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Pla
Hazard: Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.
March 12, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and t
Hazard: Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).
February 26, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their functio
Hazard: The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
February 26, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive s
Hazard: One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide.
February 26, 2014Medical DevicesFDA
Synthes, Inc. recalls Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Hazard: Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.