The Recall Desk

Manufacturer

Synthes (USA) Products LLC

164 recalls in our database name Synthes (USA) Products LLC as the manufacturing or recalling firm.

What the numbers show

Total
164
Critical
0
Severe
22
Most recent
2026-04-08

Of the 164 recalls from Synthes (USA) Products LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 22 (13%) 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.

126–150 of 164

  • ModerateFDA (Devices)·Z-1524-2016·2016-04-27

    Synthes Recalls Cervical Spine Screws Due to Lot Swapping Error

    Synthes (USA) Products LLC is voluntarily recalling specific lots of cervical spine screws because two different screw types were swapped during manufacturing.

    Product
    Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risk

    Synthes (USA) Products LLC is recalling 289 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if a surgeon attempts to remove it.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1384-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

    Synthes (USA) Products LLC is recalling 200 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks During Removal

    Synthes (USA) Products LLC is recalling 378 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures if a surgeon attempts to remove it.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

    Synthes (USA) Products LLC is recalling 212 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

    Synthes (USA) Products LLC is recalling 317 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1392-2016·2016-04-20

    Synthes OPAL Spinal Fusion Cage Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 6 units of OPAL Spacers because the outer packaging label does not match the product inside or its intended use.

    Product
    Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1327-2016·2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, potentially compromising the device's structural integrity.

    Product
    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and sel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2016·2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, which may affect the device's structural integrity.

    Product
    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and sel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1312-2016·2016-04-06

    Synthes Recalls 4.5 mm LCP Proximal Tibia Plate Systems

    Synthes (USA) Products LLC is voluntarily recalling 42 lots of 4.5 mm LCP Proximal Tibia Plate Systems due to a medical device defect.

    Product
    Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0585-2016·2016-01-13

    Synthes 13.5mm Medullary Reamer Head Recalled for Dimensional Mismatch

    Synthes (USA) Products LLC is recalling 65 units of 13.5mm Medullary Reamer Heads that are actually 14mm. The devices are distributed nationwide.

    Product
    SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2016·2015-12-16

    Synthes Recalls Five TFN-Advanced Proximal Femoral Nailing Systems

    Synthes (USA) Products LLC is recalling five TFN-Advanced Proximal Femoral Nailing Systems because a design defect may prevent proper locking mechanism advancement or screw tightening.

    Product
    Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0323-2016·2015-12-02

    Synthes 2.4mm Locking Screws Recalled for Incorrect Package Insert

    Synthes (USA) Products LLC is recalling 229 units of 2.4mm Locking Screws because they may contain the wrong package insert.

    Product
    2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0276-2016·2015-11-25

    Synthes Sternal ZIPFIX Application Instrument Recall for Screw Failure Risk

    Synthes is recalling 267 previously repaired Sternal ZIPFIX Application Instruments because the screws may break or loosen.

    Product
    Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0236-2016·2015-11-18

    Synthes Recalls Small Notch Titanium Reconstructive Plate Sets

    Synthes is recalling Small Notch Titanium Reconstructive Plate sets because they are being used in spine surgeries, which is a contraindicated use for these trauma products.

    Product
    Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0192-2016·2015-11-04

    Synthes Threaded Plate Holder Recalled for Incorrect Part Number Etching

    Synthes (USA) Products LLC is recalling 25 units of Threaded Plate Holders that are incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.

    Product
    Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0167-2016·2015-11-04

    Synthes 2.7 mm Locking Screws Recalled for Mislabeling as 2.4 mm

    Synthes (USA) Products LLC is recalling 98 units of 2.7 mm locking screws that were mislabeled as 2.4 mm. The units were distributed to Tennessee.

    Product
    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0134-2016·2015-10-28

    Synthes Recalls Spinal Pedicle Fixation Rods Due to Finishing Process Error

    Synthes (USA) Products LLC is recalling 492 spinal pedicle fixation rods because they were produced using a bead blast process not identified in the manufacturing specification.

    Product
    5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to prov
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0125-2016·2015-10-21

    Synthes Recalls Titanium Elastic Nail Inserters Due to Mechanical Failure Risk

    Synthes (USA) Products LLC is recalling 1,550 Inserter for Titanium Elastic Nails (TEN) devices due to a potential for mechanical failures such as breakage.

    Product
    Inserter for Titanium Elastic Nails (TEN), orthopedic device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0124-2016·2015-10-21

    Synthes Humerus Plates Recalled for Incorrect Part Number Labeling

    Synthes (USA) Products LLC is recalling 36 units of VA-LCP Humerus Plates because one part number was incorrectly etched on the device.

    Product
    Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the distal
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0126-2016·2015-10-21

    Synthes Screw Inserter Recalled for Incorrect Etched Graphics

    Synthes (USA) Products LLC is recalling 793 units of the Screw Inserter because the etched graphics may not correspond to the instrument's actual angle.

    Product
    Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2016·2015-10-14

    Synthes Periarticular Insertion Handles and Aiming Arms Recalled for Fit Issues

    Synthes (USA) Products LLC is recalling 172 units of Periarticular Insertion Handles and Aiming Arms because they cannot be secured to subsequent device versions as intended.

    Product
    Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2794-2015·2015-09-30

    Synthes Dynamic Locking Screw System Recalled for Pin Breakage

    Synthes (USA) Products LLC is recalling Dynamic Locking Screw Systems due to pin breakage during implant removal. This notice extends to additional consignees identified after a previous recall.

    Product
    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2811-2015·2015-09-30

    Synthes Cranial Flap Tube Clamp Recalled for Incorrect MR Safe Labeling

    Synthes (USA) Products LLC is recalling Cranial Flap Tube Clamps and Crimping Devices because they were labeled MR Safe without required testing protocols.

    Product
    Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2488-2015·2015-09-09

    Synthes Recalls VEPTR Inferior Cradles Due to Mechanical Failure Risk

    Synthes (USA) Products LLC is recalling VEPTR Inferior Cradles because a partially formed hole may cause mechanical failure, potentially requiring surgery.

    Product
    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.