TFN-ADVANCE 04.037.042SRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886982095985), received between Mar 14, 2018 and May 12, 2026 — classified as 24 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548, K160167); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE TFNA FEM NAIL Ø10 130° L170 TIMO15 EXPERIENCED AN ISSUE WITH THE LOCKING MECHANISM BEING ENGAGED PRIOR TO SHIPPING. THE EVENT RESULTED IN A SIGNIFICANT SURGICAL DELAY OF 30 MINUTES, BUT THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148203 ↗
• MalfunctionDec 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE TFNA SET SCREW WAS NOT ENGAGING WITH THE TFNA LAG SCREW ELEMENT, THEREFORE WE REMOVED THE NAIL AND IMPLANTED A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 23716965 ↗
• MalfunctionNov 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE TFNA LAG SCREW MISSED NAIL WHILE NAILING INTRAMEDULLARY. SURGEON REMOVED IMPLANT AND RESTARTED THE CASE. THE SURGERY WAS DELAYED FOR 45 MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. AIMING ARM WAS REMOVED. NO PATIENT CONSEQUENCES. NO OTHER MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512805 ↗
• MalfunctionJul 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A REMOVAL SURGERY FOR THE TFNA.AFTER THE NAIL WAS REMOVED, AN ATTEMPT WAS MADE TO REMOVE THE CONNECTION BETWEEN THE NAIL AND EXTRACTION SCREW, BUT THEY COULD NOT BE REMOVED. AN ATTEMPT WAS MADE TO REMOVE THE NAIL BY HOLDING IT IN PLACE WITH A WRENCH OR OTHER TOOL, BUT THEY COULD NOT BE REMOVED.THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613184 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS DIAGNOSED WITH POSTOPERATIVE MAL-UNION AND MAL REDUCTION OF THE RIGHT FEMUR, PROXIMAL, HIP. PATIENT HAD A REMOVAL OF NAIL, HELICAL BLADE AND SCREW. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Malunion of Bone; Physical Asymmetry

  MAUDE report 20223761 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE TFNA NAIL APPROXIMATELY TWO MONTHS AGO. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO NONUNION OF INTER TROCHANTER AND A FRACTURE BELOW THE NAIL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19688723 ↗
• MalfunctionSep 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, ONE OF THE TEAM ASSOCIATES HAD REACHED OUT TO SALES REP ABOUT COMPRESSING THE TFNA WITH THE LAG SCREW AFTER A CASE THEY HAD JUST COVERED. THE EMPLOYEE HAD THOUGHT THAT TIGHTEN DOWN THE SET SCREW AND TORQUE DOWN BEFORE COMPRESSING, AND THAT'S WHAT OCCURRED DURING THE PROCEDURE WHEN THE SURGEON ATTEMPTED TO COMPRESS. SALES REP INFORMED THE EMPLOYEE OF THE NEED TO BACK OFF THE SCREW A HALF OF TURN IN ORDER TO COMPRESS THE NAIL FRACTURE BEFORE STATICALLY LOCKING, IF THAT¿S THE CHOICE. IT WAS NOT KNOWN IF ANY ADVERSE EVENTS OCCURRED DURING THE PROCEDURE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17714299 ↗
• MalfunctionAug 25, 2023Defective Device; Migration; Defective Device; Migration

  IT WAS FURTHER REPORTED THAT THE SURGEON COMMENTED THAT A 125MM HELICAL BLADE WOULD HAVE BEEN TOO LONG. THE SURGEON WAS PLEASED WITH THE 120MM LENGTH OF THE CHOSEN HELICAL BLADE, AND NO ADVERSE EVENTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623801 ↗
• MalfunctionJul 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 THE TARGETING GUIDE FOR DISTAL SCREW ON A SHORT TFNA CAUSED THE DRILL BIT TO STRIKE THE NAIL. IT TOOK SOME EFFORT TO GET THE DRILL BIT TO PASS THROUGH THE DISTAL HOLE BUT THE SURGICAL GOAL WAS ACHIEVED AND THE OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1)10/130 DEG TI CANN TFNA 170 - STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.2 3-FLTD DRILL BIT QC/330/100 CALIB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406593 ↗
• InjuryFeb 17, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE TROCHANTERIC FIXATION NAIL - ADVANCED (TFNA) HELICAL BLADE WAS MIGRATED MEDIAL INTO ACETABULUM. THE SURGEON REMOVED THE NAIL, HELICAL BLADE AND DISTAL SCREW AND THE PATIENT WAS CONVERTED TO A TOTAL HIP. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16401003 ↗
• InjuryOct 4, 2022Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT A TFNA WITH A HELICAL BLADE ON (B)(6) 2022. AFTERWARD, ON AN UNKNOWN DATE, THE NAIL COLLAPSED AND THE HELICAL BLADE MOVED A TON LATERALLY. REVISION SURGERY IS NEEDED TO REMOVE THE HEAD ELEMENT AND REPLACE IT WITH A SHORTER ONE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15536144 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REVISION SURGERY FOR A NON-UNION FEMORAL NECK FRACTURE. THE TFNA, BLADE, AND 5MM DISTAL INTERLOCK SCREW WERE REMOVED. ANOTHER NAIL WAS INSERTED. THERE WAS NO POST-OP DEVICE MALFUNCTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15530290 ↗
• InjuryFeb 3, 2022Break; Break

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A PROCEDURE WITH BROKEN TROCHANTERIC FIXATION NAIL - ADVANCED (TFNA). PATIENT CONSEQUENCES WERE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). UNKNOWN SCREWS: LOCKING: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). UNK - END CAPS: TFNA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) 10/130 DEG TI CANN TFNA 170 - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13441812 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY OF THE TFNA IMPLANTS IN QUESTION DUE TO FRACTURE DISPLACEMENT. THE ORIGINAL IMPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2021. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13118194 ↗
• MalfunctionDec 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT IS SCHEDULED FOR TFNA REVISE DUE TO FRACTURE DISPLACEMENT. DURING EXTRACTION THE NAIL WAS VERY DIFFICULT TO CONNECT THE EXTRACTOR. THE SET SCREW WAS BACK OUT ENOUGH TO REMOVE THE LAG SCREW AND THE SMITH AND NEPHEW CONICAL EXTRACTOR WAS CONNECTED AND THE NAIL WAS SUCCESSFULLY REMOVED. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 10/130 DEG TI CANN TFNA 170 - STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13113660 ↗
• InjuryAug 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT HAD A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) SYSTEM IMPLANTED ON (B)(6) 2021. POSTOPERATIVELY THE HELICAL BLADE RETREATED FROM INSERTION POINT OF THE FEMORAL INTO THE SUBCUTANEOUS LAYER. UPON INSPECTION OF LOCKING MECHANISM THE SURGEON DETERMINED THAT THE DEVICE WAS NEVER ENGAGED. THE PATIENT ALSO HAD AN INFECTION THAT REQUIRED HARDWARE REMOVAL WHICH WAS DONE ON (B)(6) 2021. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12380452 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A NAIL REMOVAL WAS PERFORMED AND THE PATIENT WAS CONVERTED TO A BALL JOINT. THE ORIGINAL IMPLANTATION DATE IS UNKNOWN. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR 1 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12086385 ↗
• InjuryDec 17, 2020Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) WAS BROKEN AT THE HELICAL BLADE JUNCTION. THE IMPLANT WAS ORIGINALLY PLACED IN (B)(6) OF 2020. REVISION SURGERY WILL TAKE PLACE ON AN UNKNOWN DATE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: TFNA HELICAL BLADE (PART# 04.038.405; LOT# UNKNOWN; QUANTITY: 1) LOCKING SCREW (PART# 04.005.524; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR 1 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11032340 ↗
• MalfunctionNov 4, 2020Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT UNDERWENT FOR IM NAILING OF PROXIMAL FEMUR FIX. DURING THE PROCEDURE, LOCKING MECHANISM DOES NOT FULLY SEATED. PRONG MOST LIKELY DID NOT HAVE ENOUGH SPACE TO PASS INTO BETWEEN GROOVE IN BLADE AND INSIDE WALL OF TFNA NAIL. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER. (PART# 04.005.524S; LOT# 54P3760; QUANTITY: 1). THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS FOR (1) UNK - SCREWS: TRAUMA. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10787515 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL OF THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, LAG SCREW AND DISTAL LOCKING SCREW DUE TO HIP PAIN. DURING THE REMOVAL PROCEDURE, ALL DEVICES WERE SUCCESSFULLY REMOVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 170MM, STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10727737 ↗
• InjuryOct 6, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SHORT NAIL WAS BROKE AT THE JUNCTION OF THE BLADE. ON (B)(6) 2019, PATIENT RECEIVED A SHORT TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FOR AN UNSTABLE INTERTROCHANTERIC FRACTURE. ON (B)(6) 2020 PATIENT UNDERWENT SURGERY FOR REMOVAL OF BROKEN HARDWARE AND RECEIVED A TOTAL HIP REPLACEMENT. A SECOND SURGERY DUE TO HW FAILURE. FRAGMENTS GENERATED FROM BROKEN DEVICE AND WAS DIFFICULT AND REQUIRED ADDITIONAL INTERVENTION TO REMOVE AS EXPECTED BY THE SURGEON. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: FENESTRATED HELICAL BLADE 90MM (PART#: 04.038.390, LOT#: H835094, QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10634650 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) IMPLANTS DUE TO HIP ARTHRITIS AND DECREASED RANGE OF MOTION (ROM). THE PATIENT WAS THEN REVISED WITH A TOTAL HIP ARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR 1 10MM/130 DEG TI CANN TFNA 170MM-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Arthritis; No Code Available

  MAUDE report 10465605 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A PROCEDURE TO HAVE THE TFNA SYSTEM IMPLANTED. DURING THE PROCEDURE, THE SURGEON INTRODUCED THE NAIL, PASSED THE TRACTION SCREW, LOCKED IT AND WHEN THE COMPRESSION WAS MADE, THE FRACTURE IS DISTRACTED. THE SURGEON PERFORMED AUGMENTATION IN WHICH THE CEMENT CAME OUT AND WENT TO THE FOCUS OF THE FRACTURE WITHOUT LEAVING IT. THERE WAS PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10462192 ↗
• InjuryFeb 25, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) AS THE SHORT NAIL BROKE. IT WAS ORIGINALLY IMPLANTED IN SEPTEMBER. THE PATIENT DID NOT HEAL AND THE IMPLANT BROKE. EVERYTHING WAS REMOVED SUCCESSFULLY, AND THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY WITH TROCHANTERIC REATTACHMENT DEVICE. THERE WAS A PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1); UNKNOWN LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1); UNKNOWN END CAP (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS IS REPORT 01 OF 01 OF (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 9751810 ↗
• InjuryJan 9, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE (PROXIMAL FEMORAL NAILING SYSTEM TFNA) NAIL BROKE AT THE NAIL-LAG SCREW CROSS SECTION. THE PATIENT NEEDS REVISION SURGERY. THE PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA HELICAL BLADE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1); UNKNOWN TFNA END CAP (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1); UNKNOWN LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 9569989 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548, K160167. One submission often covers many models, so check the product and lot details in each record.

• Z-1239-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
• Z-1240-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima