Recall archive
59 recalls · page 1 of 3
Reported Apr 8, 2026
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps…
1 more product in this recall
FDA (openFDA device enforcement)
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws,…
FDA (openFDA device enforcement)
Reported Mar 13, 2024
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — Products not sterilized, sterility cannot be confirmed
8 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 22, 2023
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2022
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 12, 2022
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may…
FDA (openFDA device enforcement)
Reported May 18, 2022
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Reason for recall — DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include:…
FDA (openFDA device enforcement)
Reported Feb 16, 2022
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may…
FDA (openFDA device enforcement)
Reported Dec 23, 2020
DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 11, 2020
DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2020
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and…
FDA (openFDA device enforcement)
Reported Nov 20, 2019
MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — Modified outside of approved manufacturing process
FDA (openFDA device enforcement)
Reported Nov 6, 2019
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — The subject product measures 4.0mm in diameter instead of 3.5mm.
FDA (openFDA device enforcement)
Reported Oct 31, 2018
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were…
FDA (openFDA device enforcement)
Reported Jun 27, 2018
Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 30, 2018
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely…
FDA (openFDA device enforcement)
Reported May 16, 2018
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2018
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
FDA (openFDA device enforcement)
Reported Mar 8, 2017
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand — These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut. The item etched…
FDA (openFDA device enforcement)
Reported Feb 8, 2017
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
FDA (openFDA device enforcement)
Reported Dec 28, 2016
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.
FDA (openFDA device enforcement)
Reported Dec 7, 2016
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
Matched: Brand · Product · Product details — Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.
FDA (openFDA device enforcement)
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