PlainRecalls

Synthes (USA) Products LLC

98 recalls on record · Latest: Oct 29, 2025

Synthes (USA) Products LLC Recall Insight

Synthes (USA) Products LLC appears on 98 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.117% 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 Oct 29, 2025, 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, 42 moderate, and 8 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 Nov 30, 2016 to Oct 29, 2025.

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 Moderate Oct 29, 2025

LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA…

FDA Devices Moderate Jun 5, 2024

STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Par…

FDA Devices Moderate Mar 13, 2024

Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S

FDA Devices Moderate Mar 13, 2024

RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (…

FDA Devices Moderate Mar 13, 2024

13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle de…

FDA Devices Moderate Mar 13, 2024

TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S

FDA Devices Moderate Mar 13, 2024

1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S

FDA Devices Moderate Mar 13, 2024

VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S

FDA Devices Moderate Mar 13, 2024

2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S

FDA Devices Moderate Mar 22, 2023

TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. …

FDA Devices Moderate Mar 22, 2023

TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. …

FDA Devices Moderate Oct 26, 2022

SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910

FDA Devices Moderate Oct 26, 2022

DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

FDA Devices Moderate May 18, 2022

Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm.…

FDA Devices Moderate Feb 16, 2022

Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailin…

FDA Devices Moderate Dec 23, 2020

DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S

FDA Devices Moderate Dec 23, 2020

DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S

FDA Devices Moderate Dec 23, 2020

DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S

FDA Devices Moderate Dec 23, 2020

DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S

FDA Devices Moderate Dec 23, 2020

DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S

FDA Devices Moderate Dec 23, 2020

DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S

FDA Devices Moderate Dec 23, 2020

DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S

FDA Devices Moderate Dec 23, 2020

DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S

FDA Devices Moderate Dec 23, 2020

DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S

FDA Devices Low Nov 11, 2020

END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - 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/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervica…

FDA Devices Low Nov 11, 2020

SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, thoracic an…

FDA Devices Low Nov 11, 2020

STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar …

FDA Devices Low Nov 11, 2020

END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar s…

FDA Devices Low Nov 11, 2020

3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and…

FDA Devices Low Nov 11, 2020

SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lu…

FDA Devices Low Nov 11, 2020

SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lu…

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 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 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 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 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

Nearby Manufacturers

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Data Sources

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