Synthes (USA) Products recalls

Synthes (USA) Products has 164 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 8 Apr 2026. 24 are still ongoing. 4 were reported in the last 12 months.

Total recalls164since 2012

Last 12 months4reported

Class I11% of total

Ongoing24latest 8 Apr 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 2Oct 0 0 0Jan '26 0 0 2Apr 0 0 0Jul 0 0

Severity split

Class I 1 1%Class II 148 90%Class III 15 9%

Why synthes (usa) products is recalled

Product types

By year

202621%
202521%
2024106%
202332%
202274%
20203320%
201921%
2018159%
201721%
20166037%

Ongoing synthes (usa) products recalls

24 active

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	2.4 Volt(tm) Tap Cortex Screw recalled by Synthes (USA) Products	Synthes (USA) Products	Other	Nationwide
8 Apr 2026Device	CLASS II	2.4 Volt Tap Locking Screw Tap recalled by Synthes (USA) Products	Synthes (USA) Products	Other	Nationwide
29 Oct 2025Device	CLASS II	Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled	Synthes (USA) Products	Packaging Defects	Nationwide
29 Oct 2025Device	CLASS II	Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled	Synthes (USA) Products	Packaging Defects	Nationwide
5 Jun 2024Device	CLASS II	Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended recalled	Synthes (USA) Products	Other	Nationwide
13 Mar 2024Device	CLASS II	TFNA Femoral Nail, right, 130¿, L-Intended recalled	Synthes (USA) Products	Sterility	Nationwide

All synthes (usa) products recalls, newest first

164 total

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	2.4 Volt(tm) Tap Cortex Screw recalled by Synthes (USA) Products	Synthes (USA) Products	Other	Nationwide
8 Apr 2026Device	CLASS II	2.4 Volt Tap Locking Screw Tap recalled by Synthes (USA) Products	Synthes (USA) Products	Other	Nationwide
29 Oct 2025Device	CLASS II	Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled	Synthes (USA) Products	Packaging Defects	Nationwide
29 Oct 2025Device	CLASS II	Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled	Synthes (USA) Products	Packaging Defects	Nationwide
5 Jun 2024Device	CLASS II	Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended recalled	Synthes (USA) Products	Other	Nationwide
13 Mar 2024Device	CLASS II	TFNA Femoral Nail, right, 130¿, L-Intended recalled	Synthes (USA) Products	Sterility	Nationwide
13 Mar 2024Device	CLASS II	RIA Tube Assembly, minimum length, sterile- intended recalled	Synthes (USA) Products	Sterility	Nationwide
13 Mar 2024Device	CLASS II	Drill Bit/QC/Gold/ Sterile-surgical, orthopedic recalled	Synthes (USA) Products	Sterility	Nationwide
13 Mar 2024Device	CLASS II	Va-lcp Clavicle Plate 2.7, shaft, CS1, right-Intended recalled	Synthes (USA) Products	Sterility	Nationwide
13 Mar 2024Device	CLASS II	Drill Bit/QC/ Sterile-surgical, orthopedic recalled	Synthes (USA) Products	Sterility	Nationwide
13 Mar 2024Device	CLASS II	TFNA Femoral Nail, right, 130¿, L-Intended recalled	Synthes (USA) Products	Sterility	Nationwide
13 Mar 2024Device	CLASS II	Titanium Hindfoot Arthrodesis Cannulated Nails EX recalled	Synthes (USA) Products	Sterility	Nationwide
13 Mar 2024Device	CLASS II	Rapidsorb IPS Battery Pack, Sterile-Intended for use recalled	Synthes (USA) Products	Sterility	Nationwide
13 Mar 2024Device	CLASS II	Opal, Intervertebral Cage, 10x32mm, h recalled by Synthes (USA) Products	Synthes (USA) Products	Sterility	Nationwide
22 Mar 2023Device	CLASS II	Tfn-Advanced Femoral Nail/130 Deg TI Cann Tfna Sterile recalled	Synthes (USA) Products	Other	Nationwide
22 Mar 2023Device	CLASS II	Tfn-Advanced Femoral Nail/125 Deg TI Cann Tfna - Sterile recalled	Synthes (USA) Products	Other	Nationwide
22 Mar 2023Device	CLASS II	Tfn-Advanced Femoral Nail/125 Deg TI Cann Tfna Sterile recalled	Synthes (USA) Products	Other	Nationwide
26 Oct 2022Device	CLASS II	Speed 15X12X12mm Continuous Compression Implant, Product No. SE recalled	Synthes (USA) Products	Sterility	Nationwide
26 Oct 2022Device	CLASS II	SPEEDSHIFT20x20x20 Offset Implant Drill Kit, Product No. SE recalled	Synthes (USA) Products	Sterility	Nationwide
26 Oct 2022Device	CLASS II	DePuy Synthes Hammertoe Continuous Compression Implants recalled	Synthes (USA) Products	Sterility	Nationwide
26 Oct 2022Device	CLASS II	Speed 9X10X10mm Continuous Compression Implant, Product No. SE recalled	Synthes (USA) Products	Sterility	Nationwide
12 Oct 2022Device	CLASS II	Hammertoe Continuous Compression Implant (CCI) Kit recalled	Synthes (USA) Products	Foreign Material	Nationwide
18 May 2022Device	CLASS II	Radial Head Replacement System Implant is a one-piece recalled	Synthes (USA) Products	Other	Nationwide
16 Feb 2022Device	CLASS II	Universal Chuck-The Universal Chuck is an Instrument Handle recalled	Synthes (USA) Products	Other	Nationwide
23 Dec 2020Device	CLASS II	DePuy Synthes Reamer Head For Ria 2 Sterile-Orthopedic recalled	Synthes (USA) Products	Device Malfunction	Nationwide
23 Dec 2020Device	CLASS II	DePuy Synthes Reamer Head For Ria 2 Sterile-Orthopedic recalled	Synthes (USA) Products	Device Malfunction	Nationwide
23 Dec 2020Device	CLASS II	DePuy Synthes Reamer Head For Ria 2 Sterile-Orthopedic recalled	Synthes (USA) Products	Device Malfunction	Nationwide
23 Dec 2020Device	CLASS II	DePuy Synthes Reamer Head For Ria 2 Sterile-Orthopedic recalled	Synthes (USA) Products	Device Malfunction	Nationwide
23 Dec 2020Device	CLASS II	DePuy Synthes Reamer Head For Ria 2 Sterile-Orthopedic recalled	Synthes (USA) Products	Device Malfunction	Nationwide
23 Dec 2020Device	CLASS II	DePuy Synthes Reamer Head For Ria 2 Sterile-Orthopedic recalled	Synthes (USA) Products	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.