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.

151–164 of 164

  • SevereFDA (Devices)·Z-2451-2015·2015-09-02

    Synthes Trauma Ex-Fix System Recalled for MR Labeling Corrections

    Synthes (USA) Products LLC is recalling the Trauma Ex-Fix System to correct MRI safety labeling. The recall identifies additional part numbers as MR Conditional and notes one serious injury.

    Product
    Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2475-2015·2015-09-02

    Synthes Sternal ZIPFIX Application Instrument Recalled Due to Detaching End Cap

    Synthes (USA) Products LLC is recalling 451 Sternal ZIPFIX Application Instruments because the end cap may loosen and detach, rendering the instrument non-functional.

    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
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2015·2015-08-26

    Synthes Sciatic Nerve Retractor Recall for Potential Fluid Ingress

    Synthes (USA) Products LLC is recalling 1,113 Sciatic Nerve Retractors due to a potential for micropores to form, which could allow fluid to enter the hollow handle.

    Product
    Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2425-2015·2015-08-26

    Synthes Medical Nail Wraps Recalled for Insufficient Multi-Use Testing

    Synthes (USA) Products LLC is recalling specific tibial and intramedullary nail wraps because they lack sufficient testing to be considered multi-use items.

    Product
    Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail dur
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2359-2015·2015-08-19

    Synthes Recalls 8.5mm Reamer Heads for Potential Intraoperative Breakage

    Synthes (USA) Products LLC is recalling 8.5mm Reamer Heads for Flexible Intramedullary Nailing Systems due to the possibility of intraoperative breakage and un-retrieved material fragments.

    Product
    8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2272-2015·2015-08-05

    Synthes Maxillary Plates Recalled for Incorrect Laser Etch Orientation

    Synthes (USA) Products LLC is recalling 31 pre-bent maxillary plates due to potential incorrect laser etch denoting orientation.

    Product
    Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2015·2015-07-22

    Synthes Recalls Helical Blade Inserter for TFNA Due to Sizing Defect

    Synthes (USA) Products LLC is recalling 32 units of the Helical Blade Inserter for TFNA because an oversized pin prevents the tool from passing through the guide sleeve.

    Product
    Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2015·2015-07-22

    Synthes Recalls 16mm Chisel Blades Due to Incorrect Size Marking

    Synthes (USA) Products LLC is recalling 100 units of 16mm Chisel Blades that were incorrectly etched as 16mm when they are actually 10mm.

    Product
    16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0931-2015·2015-01-14

    Synthes Small Electric Drive Recalled for Unintended Start and Malfunction

    Synthes (USA) Products LLC is recalling 12 Small Electric Drive units due to potential unintended starts or reverse mode failures that could cause tissue damage.

    Product
    Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0226-2015·2014-12-03

    Synthes Recalls Titanium Polyaxial Reduction Heads for Spine Screws

    Synthes (USA) Products LLC is recalling 24 Titanium Polyaxial Reduction Heads for Matrix Spine Screws because the inner diameter may not have been machined to the correct specification.

    Product
    Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0406-2014·2013-12-04

    Synthes 2.4 mm LC-DCP Plate Recalled Due to Foreign Object

    Synthes (USA) Products LLC is recalling 13 units of 2.4 mm LC-DCP Plates because a screw was found in a package labeled for the plate.

    Product
    Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0404-2014·2013-12-04

    Synthes 14.5 mm Outer Protection Sleeve Recalled for Incorrect Size

    Synthes (USA) Products LLC is recalling 55 units of 14.5 mm Outer Protection Sleeves that were incorrectly packaged as 12.0 mm units.

    Product
    Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2057-2013·2013-09-04

    Synthes VA-LCP Distal Radius Plate Labeling Recall

    Synthes (USA) Products LLC is recalling 119,891 units of 2.4mm VA-LCP Two Column Volar Distal Radius Plates due to a labeling error in the US Technique guide.

    Product
    Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2054-2012·2012-08-01

    Synthes Universal Spinal System Lamina Hooks Recalled for Incorrect Etching

    Synthes (USA) Products LLC is recalling 12 units of Universal Spinal System Lamina Hooks because they are etched with the wrong part number.

    Product
    Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature p
    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.