The Recall Desk

Manufacturer

Synthes, Inc.

43 recalls in our database name Synthes, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
43
Critical
0
Severe
1
Most recent
2020-08-05

Of the 43 recalls from Synthes, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–43 of 43

  • HighFDA (Devices)·Z-0092-2015·2014-10-29

    DePuy Synthes Radiolucent Retractor Recalled for Adhesive Tape Residue

    Synthes, Inc. is recalling 11 DePuy Synthes Radiolucent Retractors due to adhesive tape residue that poses a risk of tissue or systemic reactions.

    Product
    DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2674-2014·2014-10-01

    DePuy Synthes Recalls TI Vectra Plates Due to Missing Clips

    Synthes, Inc. is voluntarily recalling 16 units of TI Vectra Plates because clips may be missing. The plates are used for cervical spine fixation.

    Product
    DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4 Level / 64 mm part 04.613.364 lot 8143905
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2148-2014·2014-08-27

    DePuy Synthes Recalls Craniomaxillofacial Distraction System Due to Reversal Risk

    Synthes, Inc. is recalling specific lots of the DePuy Synthes Craniomaxillofacial Distraction System because the devices may reverse after surgery.

    Product
    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2014·2014-08-27

    Synthes 3.0 MM TI Cannulated Screw Set Recalled for Cytotoxicity Risk

    Synthes, Inc. is recalling 3.0 MM TI Cannulated Screw Instrument and Implant Sets that were exposed to flood water and reprocessed. Testing indicated the components may be cytotoxic.

    Product
    Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2087-2014·2014-07-30

    Synthes Orthopedic Guide Blocks Recalled for Incorrect Labeling

    Synthes, Inc. is recalling 180 Guide Blocks for the Volar Distal Radius Plate System due to incorrect package labeling. The physical parts are correctly marked, but the packaging may identify the wrong side.

    Product
    Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2014·2014-07-09

    Synthes B37 Replacement Screws Recalled for Potential Mislabeling

    Synthes, Inc. is recalling 44 B37 Replacement Screws because the package may not contain the screws identified on the label.

    Product
    Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1833-2014·2014-06-25

    Synthes External Fixation Systems Recalled for MR Labeling Changes

    Synthes, Inc. is recalling external fixation systems because labeling changes were made to reflect updated protocols for Magnetic Resonance (MR) imaging safety designations.

    Product
    Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1781-2014·2014-06-18

    Synthes Mandible Plate Cutter Recalled for Potential Corrosion

    Synthes, Inc. is recalling 14 units of the Matrix Mandible Short Cut Plate Cutter due to potential discoloration and corroded material on the tool's face.

    Product
    Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1681-2014·2014-06-11

    Synthes XRL Medium Trial Central Body Recalled for Incorrect Dimension Etching

    Synthes, Inc. is recalling two lots of the Synthes XRL Medium Trial-Central Body device because they were incorrectly etched with the wrong height dimensions.

    Product
    Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MA
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1669-2014·2014-06-04

    Synthes ProDisc-C Milling Bits Recalled Due to Breakage Risk

    Synthes, Inc. is recalling specific lots of ProDisc-C 2.0mm Milling Bits because they have an increased potential to break during use.

    Product
    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, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling optio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1456-2014·2014-04-23

    Synthes CMF Battery Powered Driver Recalled for Misleading Case Graphics

    Synthes is recalling CMF Battery Powered Drivers because the packaging graphics suggest off-label use with taps, which is not intended.

    Product
    Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1457-2014·2014-04-23

    Synthes Hohmann Retractor Recalled for Incorrect Part Number Etching

    Synthes, Inc. is recalling 20 Hohmann retractors because they were mis-etched with the wrong part number.

    Product
    The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2014·2014-04-02

    Synthes Ulna Osteotomy System Drill Template and Saw Guide Recall

    Synthes, Inc. is recalling 343 Drill Templates and Saw Guides for the Ulna Osteotomy System due to potential mechanical failure of connecting screws or K-wires.

    Product
    Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2014·2014-03-19

    Synthes Small Notch Titanium Reconstructive Plate Recalled for Contraindicated Spine Use

    Synthes, Inc. is recalling Small Notch Titanium Reconstructive Plate sets distributed for spine applications where they are contraindicated.

    Product
    Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1125-2014·2014-03-12

    Synthes 5.0mm Variable Locking Screw Recalled for Incorrect Package Insert

    Synthes, Inc. is recalling 45 units of 5.0mm Variable Locking Screws because one package contained the wrong insert.

    Product
    Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2014·2014-02-26

    Synthes Driving Cap/Threaded Recalled for Binding in Insertion Handles

    Synthes, Inc. is recalling 143 units of the Driving Cap/Threaded because the parts can bind in insertion handles, making them difficult to separate.

    Product
    Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be insert
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2014·2014-02-26

    Synthes 3.2 mm Guide Wire Recalled for Incorrect Raw Material Labeling

    Synthes, Inc. is recalling 3.2 mm Guide Wires because the label lists an incorrect raw material. The recall covers units distributed in the USA, Canada, and Switzerland.

    Product
    Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0992-2014·2014-02-26

    Synthes Matrix Mandible Short Threaded Drill Guide Recall for Labeling Error

    Synthes, Inc. is recalling 12 units of Matrix Mandible Short Threaded Drill Guides because they have a gray band instead of the green band shown in the guide.

    Product
    Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
    Category
    Medical Device
    Distribution
    3 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Synthes

company

Country
Switzerland
Founded
1954
Parent company
Johnson & Johnson

Official website

Source: Wikidata (Q503072), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.