Synthes (Usa) Products Llc
West Chester, PA
This page shows every FDA and USDA recall linked to Synthes (Usa) Products Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
162
Total Recalls
2012
First Recall
2025
Most Recent
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS.
Used in RFN-ADVANC...
Oct 21, 2025
· Device
Open, Classified
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS.
Used in RFN-ADVANC...
Oct 21, 2025
· Device
Open, Classified
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw im...
May 28, 2024
· Device
Open, Classified
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment
Part Number: 31...
Mar 1, 2024
· Device
Open, Classified
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) t...
Mar 1, 2024
· Device
Open, Classified
TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femu...
Mar 1, 2024
· Device
Open, Classified
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive pr...
Mar 1, 2024
· Device
Open, Classified
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease
Part Number: 0...
Mar 1, 2024
· Device
Open, Classified
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal ar...
Mar 1, 2024
· Device
Open, Classified
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments.
Part Number: 02...
Mar 1, 2024
· Device
Open, Classified
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment
Product C...
Mar 1, 2024
· Device
Open, Classified
TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal fem...
Mar 1, 2024
· Device
Open, Classified
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stab...
Mar 10, 2023
· Device
Open, Classified
TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stab...
Mar 10, 2023
· Device
Open, Classified
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stab...
Mar 10, 2023
· Device
Open, Classified
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT...
Oct 18, 2022
· Device
Open, Classified
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Oct 18, 2022
· Device
Open, Classified
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Oct 18, 2022
· Device
Open, Classified
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Oct 18, 2022
· Device
Open, Classified
Hammertoe Continuous Compression Implant (CCI) Kit
Part Number: 46.239.001
Oct 6, 2022
· Device
Open, Classified
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is ava...
Apr 7, 2022
· Device
Open, Classified
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available fo...
Dec 22, 2021
· Device
Open, Classified
DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.03...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.02...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.0...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.02...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.03...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument
Part Code: 03.404.0...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.0...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.01...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.0...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument
Part Code: 03.404....
Nov 19, 2020
· Device
Terminated
DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404....
Nov 19, 2020
· Device
Terminated
DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.0...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.0...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404....
Nov 19, 2020
· Device
Terminated
DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.0...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2
STERILE-Orthopedic manual surgical instrument
Part Code: 03.404...
Nov 19, 2020
· Device
Terminated
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.0...
Nov 19, 2020
· Device
Terminated
END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device...
Sep 21, 2020
· Device
Terminated
END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device...
Sep 21, 2020
· Device
Terminated
END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device...
Sep 21, 2020
· Device
Terminated
SYNMESH 22MM X 28MM 88MM HEIGHT (TI)
Product Number: 495.379 - Product Usage: is a vertebral body replacemen...
Sep 21, 2020
· Device
Terminated
END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI)
Product Number: 495.392 - Product Usage: is a vertebral...
Sep 21, 2020
· Device
Terminated
END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI)
Product Number: 495-396 - Product Usage: is a vertebral...
Sep 21, 2020
· Device
Terminated
STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device...
Sep 21, 2020
· Device
Terminated
DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI)
Product Number: 495.344 - Product Usage: is a vertebral body...
Sep 21, 2020
· Device
Terminated
SYNMESH 15MM DIA 88MM HEIGHT (TI)
Product Number: 495.366 - Product Usage: is a vertebral body replacement d...
Sep 21, 2020
· Device
Terminated
END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI)
Product Number: 495.394 - Product Usage: is a vertebral...
Sep 21, 2020
· Device
Terminated
STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement devic...
Sep 21, 2020
· Device
Terminated