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.

101–125 of 164

ModerateFDA (Devices)·Z-2197-2016·2016-07-20
Synthes Recalls 2.0mm Stardrive Screwdrivers for MR Safety Labeling Errors
Synthes (USA) Products LLC is recalling 79 units of 2.0mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.
Product
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2153-2016·2016-07-20
Synthes 6.5 mm Cancellous Screw Recalled for Labeling Mismatch
Synthes (USA) Products LLC is recalling 6.5 mm Cancellous Screws because the labeling does not match the cleared indications for use in the United States and Canada.
Product
6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basila
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2192-2016·2016-07-20
Synthes Recalls Matrix Neuro Screwdriver Blades for MR Safety Labeling Errors
Synthes (USA) Products LLC is recalling 18 Matrix Neuro Screwdriver Blades because their MR Safety labeling does not meet current ASTM standards.
Product
Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2191-2016·2016-07-20
Synthes Recalls Matrix Neuro Screwdriver Blades for MR Safety Labeling Errors
Synthes (USA) Products LLC is recalling 18 Matrix Neuro Screwdriver Blades because their MR safety labeling does not meet current ASTM standards.
Product
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2199-2016·2016-07-20
Synthes 1.1mm Drill Bit Recalled for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 19 units of 1.1mm Drill Bits because their MR safety labeling does not meet current ASTM standards.
Product
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2155-2016·2016-07-20
Synthes 4.0 mm Cortex Screw Recalled for Labeling Mismatch
Synthes (USA) Products LLC is recalling 4.0 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.
Product
4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2195-2016·2016-07-20
Synthes Recalls 34 Stardrive Screwdrivers for MR Safety Labeling Errors
Synthes (USA) Products LLC is recalling 34 units of 1.3mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.
Product
Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2190-2016·2016-07-20
Synthes Recalls Neuro Screwdriver Blades for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 26 neuro screwdriver blades because their MR safety labels do not meet current ASTM standards.
Product
Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2189-2016·2016-07-20
Synthes Low Profile Neuro Screwdriver Blade Recalled for MR Safety Labeling
Synthes (USA) Products LLC is recalling 50 units of Low Profile Neuro Screwdriver Blades because the MR Safety information etched or labeled on the devices does not meet current ASTM standards.
Product
Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2193-2016·2016-07-20
Synthes Recalls Surgical Handles for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 29 surgical handles because their MR safety labels do not meet current ASTM standards.
Product
Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2194-2016·2016-07-20
Synthes Recalls 1.3mm Stardrive Screwdrivers for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 75 units of 1.3mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.
Product
Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implan
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2196-2016·2016-07-20
Synthes Recalls 1.5mm Stardrive Screwdrivers for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 383 units of 1.5mm Stardrive Screwdrivers because their MR Safety information does not meet current ASTM standards.
Product
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments an
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2154-2016·2016-07-20
Synthes Recalls 7.0 mm and 7.3 mm Cannulated Screws for Labeling Errors
Synthes (USA) Products LLC is recalling 7.0 mm and 7.3 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.
Product
7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DH
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2138-2016·2016-07-13
Synthes Ti Button Plate Recalled for Inaccurate MR Safety Labeling
Synthes (USA) Products LLC is recalling 6,255 Ti Button Plate units because their MR safety information does not meet current ASTM standards.
Product
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Category
Medical Device
Distribution
50 states
LowFDA (Devices)·Z-1949-2016·2016-06-22
Synthes Recalls Six LCP Dia-Meta Volar Distal Radius Plates Due to Packaging Error
Synthes (USA) Products LLC is recalling six LCP Dia-Meta Volar Distal Radius Plates because the preprinted outer boxes were incorrect, though the internal product labels are accurate.
Product
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1912-2016·2016-06-15
DePuy Synthes Flexible Shaft Reamers Recalled for Cytotoxicity Failure
Synthes (USA) Products LLC is recalling 244 DePuy Synthes 8.0 mm Flexible Shaft Reamers because they failed biological safety evaluations for cytotoxicity.
Product
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1919-2016·2016-06-15
Synthes Rapid Resorbable Orbital Floor Plate Recalled for Labeling Errors
Synthes (USA) Products LLC is recalling 19 units of 1.5 mm Rapid Resorbable Orbital Floor Plates due to potential expiration date discrepancies on outer packaging labels.
Product
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1942-2016·2016-06-15
DePuy Synthes Recalls Norian Drillable Inject Due to Labeling Error
DePuy Synthes is voluntarily recalling Norian Drillable Inject 3 CC-Sterile because the internal pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Product
Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1918-2016·2016-06-15
Synthes Recalls 22 Rapid Resorbable Orbital Floor Plates Due to Labeling Errors
Synthes (USA) Products LLC is recalling 22 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.
Product
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pedia
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1943-2016·2016-06-15
DePuy Synthes Recalls Norian Drillable Inject Due to Labeling Error
DePuy Synthes is voluntarily recalling Norian Drillable Inject 5 CC-Sterile units because the internal rotary pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Product
Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1920-2016·2016-06-15
Synthes Recalls 1.5 mm Rapid Resorbable Orbital Floor Plates Due to Labeling Errors
Synthes (USA) Products LLC is recalling 14 units of 1.5 mm Rapid Resorbable Orbital Floor Plates because outer package expiration dates may exceed subcomponent dates.
Product
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1944-2016·2016-06-15
Synthes Recalls Norian Drillable Inject Due to Labeling Error
Synthes (USA) Products LLC is recalling Norian Drillable Inject 10 CC-Sterile units because the internal rotary pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
Product
Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1710-2016·2016-06-01
Synthes 3.2 mm Radiolucent Drill Bits Recalled for Sterile Packaging Compromise
Synthes (USA) Products LLC is recalling 1,274 sterile 3.2 mm radiolucent drill bits because the protective cap may not be secured, risking puncture of the sterile barrier.
Product
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1709-2016·2016-06-01
Synthes 3.2 mm Drill Bits Recalled for Sterile Packaging Compromise
Synthes (USA) Products LLC is recalling 7,363 sterile 3.2 mm three-fluted drill bits because the protective cap may not be secured, allowing the tip to puncture the sterile barrier.
Product
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1574-2016·2016-05-04
Synthes Periprosthetic Locking Screw Recalled for Post-Expiration Shipment
Synthes (USA) Products LLC is recalling 15 units of 5.0 mm Periprosthetic Locking Screws shipped after their expiration date.
Product
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Category
Medical Device
Distribution
2 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.