Manufacturer

Synthes USA HQ, Inc.

56 recalls in our database name Synthes USA HQ, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 56
Critical: 0
Severe: 4
Most recent: 2014-01-08

Of the 56 recalls from Synthes USA HQ, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (7%) 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.

1–25 of 56

ModerateFDA (Devices)·Z-0615-2014·2014-01-08
Synthes Electric Pen Drive Hand Switch Recalled for Labeling Error
Synthes USA HQ, Inc. is recalling 290 Electric Pen Drive Hand Switches because the 'on' and 'lock' labels were interchanged.
Product
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0474-2014·2013-12-18
Synthes Trochanteric Fixation Nail Recalled for Incorrect Packaging Labeling
Synthes USA is recalling 12 Trochanteric Fixation Nails because the packaging incorrectly lists the nail's length and diameter.
Product
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0473-2014·2013-12-18
Synthes TomoFix Osteotomy System Recalled for Surgical Technique Guide Labeling Error
Synthes USA HQ, Inc. is recalling the TomoFix Osteotomy System due to a labeling error in the Surgical Technique Guide that may cause surgical delays.
Product
Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0452-2014·2013-12-11
Synthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend
Synthes USA is recalling 17 units of the Titanium Trochanteric Fixation Nail (TFN) System because two lots are missing a required second bend in the nail.
Product
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0455-2014·2013-12-11
Synthes Zero-P VA Implant Recalled for Potential Screw Back-Out Risk
Synthes USA is recalling specific Zero-P VA implants because a screw could back out if the blocking mechanism is not visually confirmed to cover the screw head.
Product
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying r
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0429-2014·2013-12-11
Synthes Soft Tissue Retractor Recalled for Locking Nut Malfunction
Synthes USA HQ, Inc. is recalling 374 units of the Small Extendible Soft Tissue Retractor due to a locking nut malfunction.
Product
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0391-2014·2013-12-04
Synthes Matrix Coronal Bender Recall Due to Tip Breakage
Synthes USA is recalling 209 Matrix 5.5mm Coronal Benders because tips broke during use. The devices are used for spinal stabilization.
Product
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine throug
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0390-2014·2013-12-04
Synthes Recalls 3.7mm and 5.0mm Dynamic Locking Screws Due to Breakage
Synthes USA HQ, Inc. is recalling 3.7mm and 5.0mm Dynamic Locking Screws because they may break at the distal tip during removal.
Product
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0396-2014·2013-12-04
Synthes Titanium Spinal Locking Caps Recalled for Post-Operative Loosening
Synthes USA is recalling 745 Titanium Minimally Invasive Reduction Screw System Locking Caps due to a risk of post-operative loosening if the construct is mis-aligned during final tightening.
Product
Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0395-2014·2013-12-04
Synthes Polyaxial Screw Body Recalled for Potential Post-Operative Loosening
Synthes USA is recalling 757 units of Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Bodies due to reported complaints of post-operative locking cap loosening.
Product
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0408-2014·2013-12-04
Synthes Slipped Capital Femoral Epiphysis System Recalled for Drill Bit Breakage
Synthes USA is recalling 166 units of the Slipped Capital Femoral Epiphysis System because guide wires may stick and drill bits may break during surgery.
Product
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0388-2014·2013-12-04
Synthes Tensioning Device Recalled Due to Potential Mechanical Failure
Synthes USA HQ, Inc. is recalling 369 Tensioning Devices because the reaction fork may come loose, preventing the device from applying tension or releasing the wire.
Product
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0405-2014·2013-12-04
Synthes Implant Holder Recalled Due to Breakage During Orthopedic Surgery
Synthes USA HQ, Inc. is recalling 548 Synfix (TM)-LR Implant Holders because they may break at the interface between the implant and the holder.
Product
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0401-2014·2013-12-04
Synthes 4.5mm Condylar Plate Recalled for Restricted Sales Release
Synthes USA is recalling a specific lot of 4.5mm condylar plates that were inadvertently released to a sales consultant restricted for sale.
Product
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprost
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0384-2014·2013-12-04
Synthes Matrix Threaded Persuader Recalled Due to Reduction Insert Breakage
Synthes USA HQ, Inc. is recalling 634 units of the Matrix Threaded Persuader because the Reduction Insert can break during use, preventing the instrument from functioning.
Product
Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0394-2014·2013-12-04
Synthes Spiked Washers Recalled Due to Mislabeled Size
Synthes USA HQ, Inc. is recalling Spiked Washers 13.5/6.5 because they were mislabeled as 13.5/5.5 during a retrospective assessment.
Product
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0410-2014·2013-12-04
Synthes Recalls Vertebroplasty Needle Kits Due to Expiration Date Inconsistencies
Synthes USA is recalling 40 Vertebroplasty Needle Kits because of inconsistent expiration dates on the packaging.
Product
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0380-2014·2013-12-04
Synthes 2.4 and 2.7 mm Locking Screws Recalled for Mislabeling
Synthes USA is recalling 98 units of 2.4 and 2.7 mm Locking Screws because 2.7 mm screws were incorrectly labeled as 2.4 mm.
Product
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0387-2014·2013-12-04
Synthes Large Buttress Compression Nut Recalled for Threading Defect
Synthes USA is recalling 135 Large Buttress Compression Nuts for Blade Guide Sleeve TFN because the nuts did not thread completely and became stuck.
Product
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0409-2014·2013-12-04
Synthes 4.5 mm LCP Curved Condylar Plate Recalled for Mislabeling
Synthes USA HQ, Inc. is recalling 13 units of the 4.5 mm LCP Curved Condylar Plate because straight plates are etched with the curved plate's part number.
Product
Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0393-2014·2013-12-04
Synthes Material Mix Surgical Instruments Recalled Due to Material Error
Synthes USA is recalling approximately 44 surgical instruments because a material batch was mixed with an incorrect material having lower hardness and corrosion resistance.
Product
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody di
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0407-2014·2013-12-04
Synthes Titanium Humeral Nail Recalled for Incorrect Packaging Labeling
Synthes USA is recalling 14 Titanium Cannulated Humeral Nails because the packaging incorrectly depicts the device as having 3 distal holes instead of 2.
Product
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0341-2014·2013-11-27
Synthes Soft Tissue Retractor Recalled for Potential Nut Breakage
Synthes USA HQ, Inc. is recalling 374 Soft Tissue Retractors because the locking screw nut may break if overtightened.
Product
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0369-2014·2013-11-27
Synthes Titanium Trochanteric Fixation Nail Recall for Non-Conforming Blades
Synthes USA is recalling Titanium Trochanteric Fixation Nail (TFN) Helical Blades due to a potential for non-conforming products to be distributed.
Product
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fra
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0202-2014·2013-11-20
Synthes 8.5 MM Medullary Reamer Recalled Due to Intraoperative Breakage
Synthes USA HQ, Inc. is recalling 2,979 units of the 8.5 MM Medullary Reamer because the reamer head can break during surgery, leaving unretrieved fragments of non-implant grade material.
Product
Synthes 8.5 MM Medullary Reamer Product Usage: 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 cerclage
Category
Medical Device
Distribution
Distributed nationwide