PlainRecalls

Synthes (USA) Products LLC

Compiled from official public sources by the editorial team.

164 recalls on record · Latest: Apr 8, 2026

Synthes (USA) Products LLC Recall Insight

Synthes (USA) Products LLC appears on 164 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.161% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 8, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 44 moderate, and 6 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Jul 20, 2016 to Nov 11, 2020.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Low Nov 11, 2020

SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and…

FDA Devices Low Nov 11, 2020

END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar s…

FDA Devices Low Nov 11, 2020

END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervica…

FDA Devices Low Nov 11, 2020

END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervica…

FDA Devices Low Nov 11, 2020

STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar…

FDA Devices Low Nov 11, 2020

DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, th…

FDA Devices Moderate Aug 26, 2020

DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-…

FDA Devices Moderate Nov 20, 2019

MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handl…

FDA Devices Moderate Nov 6, 2019

Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

FDA Devices Moderate Oct 31, 2018

3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixat…

FDA Devices Moderate Jun 27, 2018

Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set

FDA Devices Moderate Jun 27, 2018

Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set

FDA Devices Moderate Jun 27, 2018

Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set

FDA Devices Moderate May 30, 2018

Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.

FDA Devices Moderate May 16, 2018

Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

FDA Devices Moderate May 16, 2018

Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630

FDA Devices Moderate Mar 14, 2018

2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Devices Moderate Mar 14, 2018

Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Devices Moderate Mar 14, 2018

2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Devices Moderate Mar 14, 2018

2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Devices Moderate Mar 14, 2018

3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthoped…

FDA Devices Moderate Mar 14, 2018

2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surge…

FDA Devices Moderate Mar 14, 2018

2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthop…

FDA Devices Moderate Feb 21, 2018

11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile

FDA Devices Moderate Mar 8, 2017

PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment…

FDA Devices Moderate Feb 8, 2017

Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacem…

FDA Devices Moderate Dec 28, 2016

Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument

FDA Devices Moderate Dec 7, 2016

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

FDA Devices Moderate Nov 30, 2016

Extraction Hook - Sterile for TI Cannulated Nails

FDA Devices Moderate Nov 30, 2016

3.0 mm Guide Rod/950 mm with Smooth Tip, sterile

FDA Devices Moderate Nov 30, 2016

3.0 mm Reaming Rod/950 mm, Sterile

FDA Devices Moderate Nov 30, 2016

2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile

FDA Devices Moderate Nov 30, 2016

Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedulla…

FDA Devices Moderate Nov 30, 2016

2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

FDA Devices Moderate Nov 30, 2016

2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile

FDA Devices Moderate Nov 30, 2016

2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile

FDA Devices Moderate Nov 30, 2016

3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile

FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for…

FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intend…

FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are inten…

FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended fo…

FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium Single Vector Distractor and Proximal Foot Plates are inten…

FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intend…

FDA Devices Moderate Aug 17, 2016

Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Rece…

FDA Devices Moderate Jul 27, 2016

Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I ex…

FDA Devices Moderate Jul 20, 2016

4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture f…

FDA Devices Moderate Jul 20, 2016

4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large…

FDA Devices Moderate Jul 20, 2016

6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of l…

FDA Devices Moderate Jul 20, 2016

Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700…

FDA Devices Moderate Jul 20, 2016

Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe …

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.