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 48 entries, severity tagging shows 1 critical, 47 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 48 of 48 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 (48). The date window on this page runs from Sep 4, 2013 to Nov 30, 2016.

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 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 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 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 …

FDA Devices Moderate Jul 20, 2016

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…

FDA Devices Moderate Jul 20, 2016

7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fracture fi…

FDA Devices Moderate Jul 20, 2016

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: T…

FDA Devices Moderate Jul 20, 2016

6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of l…

FDA Devices Moderate Jul 20, 2016

Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePu…

FDA Devices Moderate Jul 20, 2016

Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe …

FDA Devices Moderate Jul 20, 2016

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: …

FDA Devices Moderate Jul 20, 2016

3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fi…

FDA Devices Moderate Jun 15, 2016

Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsi…

FDA Devices Moderate Jun 15, 2016

DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43

FDA Devices Moderate Jun 15, 2016

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 …

FDA Devices Moderate Jun 1, 2016

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 c…

FDA Devices Moderate Jun 1, 2016

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 …

FDA Devices Moderate May 4, 2016

5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.

FDA Devices Moderate Apr 27, 2016

Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm L…

FDA Devices Moderate Apr 20, 2016

SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Du…

FDA Devices Moderate Apr 20, 2016

SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Du…

FDA Devices Moderate Apr 20, 2016

SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Du…

FDA Devices Moderate Apr 13, 2016

Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is inte…

FDA Devices Moderate Jan 13, 2016

SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.

FDA Devices Moderate Dec 2, 2015

2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of …

FDA Devices Moderate Nov 25, 2015

Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternot…

FDA Devices Moderate Nov 18, 2015

Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.

FDA Devices Moderate Nov 4, 2015

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, ost…

FDA Devices Moderate Oct 21, 2015

Inserter for Titanium Elastic Nails (TEN), orthopedic device

FDA Devices Moderate Sep 30, 2015

Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial …

FDA Devices Moderate Sep 2, 2015

Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures…

FDA Devices Moderate Sep 2, 2015

Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotom…

FDA Devices Moderate Aug 26, 2015

Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specifi…

FDA Devices Moderate Aug 19, 2015

8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for …

FDA Devices Moderate Jan 14, 2015

Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand an…

FDA Devices Critical Dec 3, 2014

Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine Syste…

FDA Devices Moderate Dec 4, 2013

Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthe…

FDA Devices Moderate Sep 4, 2013

Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended fo…

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