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.

26–50 of 56

SevereFDA (Devices)·Z-0114-2014·2013-11-06
Synthes Sternal Zip Flex System Recalled for Implant Cutting Risk
Synthes USA HQ, Inc. is recalling 319 units of the Sternal Zip Flex System because the application instrument may cut the implant, leading to loosening.
Product
Synthes Application Instrument Sternal Zip Flex System intended for use in 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-0014-2014·2013-10-23
Synthes Midfoot Fusion Bolt Recall for Technique Guide Clarification
Synthes USA is recalling 62 Midfoot Fusion Bolts to update the technique guide, emphasizing supplemental fixation to reduce the risk of bolt back-out or migration.
Product
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2282-2013·2013-10-02
Synthes Oracle Spacer System Slap Hammer Recalled for Breakage During Use
Synthes USA HQ, Inc. is recalling 27 units of the Oracle Spacer System Slap Hammer because the proximal end broke during use.
Product
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combi
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-2278-2013·2013-10-02
Synthes 3.5 MM LCP Distal Humerus System Recalled for Mislabeled Part Numbers
Synthes USA HQ, Inc. is recalling two units of the 3.5 MM LCP Distal Humerus System because the part was mislabeled with an incorrect part number.
Product
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2243-2013·2013-09-25
Synthes Cannulated Distal Femoral Nail Recalled Due to Prior Recall Scope
Synthes USA is recalling one unit of a Cannulated Distal Femoral Nail because it was distributed despite being within the scope of a previous recall.
Product
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2087-2013·2013-09-04
Synthes 2.4 mm VA-LCP Distal Radius Plate Recall for Mislabeling
Synthes USA HQ, Inc. is recalling 11 units of 2.4 mm VA-LCP distal radius plates that may be incorrectly etched with 'R' instead of 'L'.
Product
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: 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-2058-2013·2013-09-04
Synthes Trauma Nail System Recalled for Potential Outer Pouch Compromise
Synthes USA HQ, Inc. is recalling Trauma Nail Systems because the outer packaging pouch may be compromised, potentially affecting the sterile internal pouch.
Product
Synthes Trauma Nail System. The devices are indication for bone fixation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1952-2013·2013-08-21
Synthes Flexible Medullary Reamer Recalled Due to Cleaning and Corrosion Risks
Synthes USA is recalling 13,050 Flexible Medullary Reamers because the coiled design makes them difficult to clean, creating a risk of corrosion and foreign material introduction.
Product
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1935-2013·2013-08-21
Synthes Recalls 5.0mm Stainless Steel Spinal Rods Due to Process Error
Synthes USA is recalling 492 units of 5.0mm stainless steel spinal rods because they were produced using a finishing 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 pedicle screw spinal system; Intended to provide immobil
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1821-2013·2013-08-07
Synthes Synapse SD Drill Guide Recalled for Incorrect Etching
Synthes USA HQ, Inc. is recalling two Synapse SD Drill Guides with incorrect etching. The error could lead to the use of the wrong drill size during surgery.
Product
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook an
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1816-2013·2013-08-07
Synthes Large External Fixation Tube to Tube Clamp Recalled for Incorrect Insert
Synthes USA HQ, Inc. is recalling 8 units of Large External Fixation Tube to Tube Clamps because the provided insert incorrectly states the device is MR Safe instead of MR Conditional.
Product
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1726-2013·2013-07-24
Synthes CMF Distraction System Recalled for Misalignment
Synthes USA HQ, Inc. is voluntarily recalling 10 units of the Synthes CMF Distraction System due to a misalignment issue that prevents the attachment of specific foot plates.
Product
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1745-2013·2013-07-24
Synthes Recalls Multi Vector Distractor Pin Holding Clamps Due to Binding
Synthes USA is voluntarily removing Multi Vector Distractor Pin Holding Clamps because the clamp and nut construct may fail to engage threads and bind.
Product
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Di
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1557-2013·2013-06-26
Synthes 11-Hole Tubular Plate Recalled Due to Error in Release
Synthes USA HQ, Inc. is recalling 10 units of 11-Hole, 1/3 Tubular Plate DCL Plates with Collar because they were released to the US market in error.
Product
Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1238-2013·2013-05-15
Synthes Radial Head Prosthesis Recalled Due to Potential Component Separation
Synthes USA is recalling 417 trial radial head prostheses because the trial head may come loose from the implant stem during surgery. No adverse events have been reported.
Product
Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ asse
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1062-2013·2013-04-17
Synthes Flexible Grip Recalled for Cleaning Limitations
Synthes USA is voluntarily recalling 328 Flexible Grip instruments from the Universal Nail System because they may not be thoroughly cleaned.
Product
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1016-2013·2013-04-03
Synthes Dens Instrument Set Recalled Due to Lack of Indicated Screws
Synthes USA HQ, Inc. is recalling 148 Dens Instrument Sets because there are no screws specifically indicated for the procedure.
Product
Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0956-2013·2013-03-27
Synthes Recalls Four Mis-etched Variable Angle Locking Compression Plates
Synthes USA is recalling four Variable Angle Locking Compression Plates that were incorrectly etched with the wrong part number.
Product
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0938-2013·2013-03-20
Synthes Spine Pedicle Screw Recalled for Incorrect Length Etching
Synthes USA HQ, Inc. is recalling 18 units of 45 mm Click 'X Pedicle Screws because they were incorrectly etched as 40 mm.
Product
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0942-2013·2013-03-20
Synthes Titanium Midface Distractor Recalled Due to Fit Issues
Synthes USA is recalling 596 Titanium Midface Distractors because oversized tabs may prevent footplates from fitting properly.
Product
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0941-2013·2013-03-20
Synthes Large Combination Clamp Recalled Due to Oversized Hex Nuts
Synthes USA is recalling 136 Large Combination Clamps because oversized hex nuts prevent standard 11 mm sockets and wrenches from fitting.
Product
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0905-2013·2013-03-13
Synthes Multi-Vector Distractor Recalled for Non-Conforming Shear Pin
Synthes USA is recalling 18 Multi-Vector Distractors because the shear pin may not meet product specifications.
Product
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0904-2013·2013-03-13
Synthes Multi-Vector Distractor Recalled Due to Shear Pin Specification Issues
Synthes USA is recalling 24 Multi-Vector Distractors because the sheer pin may not meet product specifications. The devices are used for mandibular bone lengthening.
Product
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0903-2013·2013-03-13
Synthes Multi-Vector Distractor Body Recalled for Manufacturing Defect
Synthes USA HQ, Inc. is recalling two units of the Multi-Vector Distractor Body because the sheer pin may not meet product specifications.
Product
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0782-2013·2013-02-13
Synthes Spine Vectra Adjustable Drill Stop Recalled for Slip Risk
Synthes USA is recalling 48 units of the Spine Vectra Adjustable Drill Stop because the device may slip on the drill bit, posing a risk of adverse events during surgery.
Product
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the ce
Category
Medical Device
Distribution
Distributed nationwide