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NA 314.742Recalls & reported problems

Synthes GmbH · DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA · Class 1

Adverse event reports
23
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982189035), received between Dec 18, 2017 and Mar 30, 2023 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (21 reports).

18 other recalls cover devices cleared under the same FDA submission (K013527, K042899); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break21
  • Device-Device Incompatibility1
  • Entrapment of Device1
  • Material Fragmentation1
  • Material Integrity Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions12
  • No Consequences Or Impact To Patient4
  • No Patient Involvement3
  • Foreign Body In Patient2
  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE RIA WAS ASSEMBLED WITH THE RIA 360 DRIVE SHAFT AND THE 12MM TRIMMING HEAD, WHICH BROKE AT THE MOMENT OF REAMING THE FEMORAL CANAL. AFTERWARD, THEY PASSED THE 13MM TRIMMING HEAD WHICH WAS MOUNTED ON THE RIA 520 TO CONTINUE THE EXTRACTION OF GRAFT FROM THE CANAL. THE HEAD AND PROXIMAL PART OF THE DRIVING SHAFT WERE SPLIT AGAIN. IT WAS NOT POSSIBLE TO REMOVE THE HOSE SYSTEM OF THE RIA L360 FROM ITS DRIVE SHAFT, SO IT WAS COVERED WITH LATEX GLOVES. THE PROCEDURE WAS NOT A SUCCESS. THE SURGEON WAS NOT ABLE TO REMOVE THE REQUIRED GRAFT AND THE WOUND WAS CLOSED. DUE TO THE DAMAGE OF THE TWO MILLING CUTTERS AND THE DRIVE SHAFT, IT WAS NOT POSSIBLE TO TAKE THE GRAFT THAT THE PATIENT NEEDED TO FILL THE DEFECT BECAUSE IT WAS A RECONSTRUCTIVE SURGERY THAT REQUIRED A SECOND SURGICAL TIME, WITH THE POSSIBILITY AND RISK OF INFECTION. THIS REPORT INVOLVES RIA DRIVESHAFT L360 THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16645122 ↗
  • MalfunctionMar 21, 2023Break; Break

    DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AT THE TIME OF MILLING, A SOUND WAS HEARD. WHEN FINISHING AND DISMANTLING THE SYSTEM, IT WAS EVIDENT THAT THE TIP OF THE TREE IS BURST. THIS REPORT INVOLVES ONE DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16583840 ↗
  • MalfunctionMar 21, 2023Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SHAFT TIP OF THE RIA L360 TRANSMISSION AND THE ANCHOR PART OF THE RIA 12 MILLING HEAD SPLIT DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16583110 ↗
  • MalfunctionJan 23, 2023Material Integrity Problem; Material Integrity Problem

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE RIA L360 DRIVE SHAFT DAMAGED THE TIP IN SURGERY. THE MANUAL MEDULLARY DRILL BROKE IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS OK. NO FRAGMENTS WERE GENERATED, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16225722 ↗
  • InjuryOct 13, 2022Break; Entrapment of Device; Break; Entrapment of Device

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE END OF THE L360 DRIVE SHAFT AND THE LEGS OF THE 12 MM RIA MILLING CUTTER ARE SPLIT. PARTICLES REMAINING IN THE CHANNEL. THIS REPORT INVOLVES ONE DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: Foreign Body In Patient

    MAUDE report 15598750 ↗
  • MalfunctionSep 28, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DEVICE BROKE INTRAOPERATIVELY. THERE WAS NO CONSEQUENCE TO A PATIENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15499036 ↗
  • MalfunctionJun 13, 2022Break; Break

    DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE DRIVE SHAFT BROKE AFTER THE CLIP CAME LOOSE AND DISASSEMBLED FROM THE L360 HOSE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14677125 ↗
  • MalfunctionJun 3, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2022 A REAMER HEAD AND RIA DRIVE SHAFT MALFUNCTIONED. DURING THE REAMING, THE FINS OF THE 12 DIAMETER HEAD FRACTURED AND WHEN THE SPECIALIST FINISHED AND PULLS OUT THE DRIVE SHAFT L360 IT IS EVIDENT THAT IT IS ALSO SPLIT AT THE END WHERE THE CUTTER IS POSITIONED. NO PATIENT HARM WAS REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR A RIA DRIVE SHAFT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14597681 ↗
  • MalfunctionApr 15, 2022Break; Break

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE DISTAL PART OF THE RIA DRIVE SHAFT BROKE WHERE THE DRILL FITS. NO BROKEN FRAGMENT RETAINED IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14120651 ↗
  • MalfunctionOct 20, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE RIA TRANSMISSION SHAFT WAS SPLIT. ALL FRAGMENTS ARE REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12665191 ↗
  • MalfunctionOct 7, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE DEVICE WAS RECEIVED AS BLIND UNIT. HOWEVER, IT COULDN¿T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12590756 ↗
  • MalfunctionAug 2, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING THE PROCEDURE, THE TIP OF THE DRIVE SHAFT BROKE. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12258902 ↗
  • MalfunctionApr 12, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, AT THE END OF THE REAMING OF THE MEDULLARY CANAL OF THE TIBIA, THE TIP OF THE TRANSMISSION 360 MM TREE WAS SPLIT. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THERE WAS A SURGICAL DELAY OF APPROXIMATELY THIRTY (30) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENTS STATUS WAS REPORTED AS GOOD. THIS REPORT INVOLVES ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11648705 ↗
  • MalfunctionJul 23, 2020Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN INCOMING INSPECTION THE DRIVE SHAFT WAS DISCOVERED AS BROKEN OFF AT THE TIP. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 10314065 ↗
  • MalfunctionNov 21, 2019Break; Break

    THE PROBLEM COULD BE SOLVED BUT THE DOCTOR INQUIRED ABOUT MAINTENANCE SCHEDULE OF THIS EQUIPMENT AS IT IS IN CONSTANT USE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9357122 ↗
  • MalfunctionNov 4, 2019Break; Break

    DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ON AN UNKNOWN DATE, DURING AN IN-HOUSE INSPECTION, THE SHAFT IN FRONT ON AN RIA DRIVESHAFT L360, IS FOUND TO BE BROKEN. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) RIA DRIVESHAFT L360. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 9270772 ↗
  • MalfunctionMar 21, 2019Break; Break

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE REAMER/ IRRIGATOR/ ASPIRATOR (RIA) DRIVE SHAFT OF THE RIA SYSTEM BROKE WHILE REAMING. IT WAS NOTED NO FRAGMENTS WERE GENERATED WHEN THE DEVICE BROKE. IT WAS A STANDARD SITUATION UPON REAMING THE RIA SYSTEM FORWARD AND BACKWARD. THE SURGEON USED ANOTHER RIA DRIVE SHAFT AS WELL AS THE ASSEMBLY TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES WITH NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: RIA TUBE (PART/LOT UNKNOWN, QUANTITY 1); RIA MEDULLARY REAMER HEADS (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN RIA DRIVE SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8441208 ↗
  • MalfunctionMar 20, 2019Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE REAMER IRRIGATOR ASPIRATOR (RIA) DRIVER SHAFT BROKE OFF. IT IS UNKNOWN IF WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8436922 ↗
  • MalfunctionJul 13, 2018Break; Break

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR LEFT TIBIA PSEUDOARTHROSIS ON (B)(6) 2018. DURING THE SURGERY, THE DRIVE SHAFT USED FOR REAMER/IRRIGATOR/ASPIRATOR (RIA) BROKE AT THE TIME OF PASSING AND REMOVING IT. THE REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM WAS ASSEMBLED AND TESTED BEFORE USED. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7685533 ↗
  • InjuryJun 27, 2018Break; Material Fragmentation; Break; Material Fragmentation

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN INTRAMEDULLARY CANAL LAVAGE ON (B)(6) 2018, WHEN REACHING THE FRACTURE POINT THE REAMER DID NOT ADVANCE, THE SURGEON APPLIED STRENGTH TO THE REAMER BUT IT DID NOT ADVANCE. IT WAS FOUND OUT THAT THE TIP OF THE DRIVE SHAFT WAS BROKEN. THE SURGEON PERFORMED AN X-RAY SCAN OF THE ENTIRE LEG OF THE PATIENT, AND A METAL WITH A DIFFERENT DENSITY IS EVIDENCED, IT IS ASSUMED TO BE THE TIP OF THE TRANSMISSION TREE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - REAMER HEAD (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: Foreign Body In Patient

    MAUDE report 7641183 ↗
  • MalfunctionJun 14, 2018Break; Break

    IT WAS REPORTED THAT DURING CHECK IN ON UNKNOWN DATE, THE SMALL REAMER SHAFT WAS BROKEN IN A REAMER/IRRIGATOR/ASPIRATOR (RIA) INSTRUMENT SET. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 7602658 ↗
  • MalfunctionApr 4, 2018Break; Break

    IT WAS REPORTED THAT A DURING A REAMER/IRRIGATOR/ASPIRATOR (RIA) BONE GRAFT HARVEST PROCEDURE ON (B)(6) 2018 A RIA DRIVE SHAFT 360MM AND A RIA TUBE ASSEMBLY 520MM BROKE IN HALF. THE RIA BONE GRAFT HARVEST WAS THE SECOND STAGE OF A PLANNED AUGMENTATION OF VARIABLE ANGLE (VA) CONDYLAR DISTAL FEMUR FIXATION. THE FIRST PROCEDURE REQUIRED REMOVAL OF ANTIBIOTIC CEMENT TO FILL BONE VOID OF A DISTAL FEMUR DEFECT. THE RIA DRIVE SHAFT 360MM AND THE RIA TUBE ASSEMBLY 520MM WERE ASSEMBLED TOGETHER AND THE SURGEON BEGAN THE FEMUR REAMING PROCESS. HOWEVER, THE RIA WOULD NOT ADVANCE PAST THE FEMORAL ISTHMUS. THE SURGEON REMOVED THE RIA ASSEMBLY FROM THE FEMUR, SUSPECTING THAT THE RIA REAMER HEAD WAS TOO LARGE. WHEN THE SURGEON REMOVED THE ASSEMBLY FROM THE FEMUR IT WAS DISCOVERED THAT THE RIA DRIVE SHAFT 360MM AND THE RIA TUBE ASSEMBLY 520MM WERE BROKEN IN HALF. A SMALL METAL FRAGMENT FELL OFF THE TIP OF THE DRIVE SHAFT, BUT WAS EASILY REMOVED. THE DEVICES WERE TAKEN TO A BACK TABLE WHERE IT WAS DISCOVERED THAT THE WRONG DRIVE SHAFT WAS CONNECTED TO THE TUBE ASSEMBLY (SHORT DRIVE SHAFT 360MM + LONG TUBE ASSEMBLY 520MM). THE SURGERY WAS COMPLETED WITHOUT INCIDENT USING A NEW RIA ASSEMBLY. THERE WA

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7397767 ↗
  • MalfunctionDec 18, 2017Break; Break

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REAMER/IRRIGATOR/ASPIRATOR (RIA) REAMING SHAFT BROKE AT THE TIP DURING THE SURGERY ON (B)(6) 2017. SURGERY TIME EXTENDED FOR THIRTY (30) MINUTES AS A RESULT OF THE INCIDENT. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7125925 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013527, K042899. One submission often covers many models, so check the product and lot details in each record.

  • Z-1237-2024 · Jan 24, 2024 · Open, Classified
    RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effective
  • Z-0587-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
  • Z-0578-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
  • Z-0579-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
  • Z-0583-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
  • Z-0577-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
  • Z-0572-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
  • Z-0584-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
  • Z-0586-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
  • Z-0581-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
  • Z-0576-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
  • Z-0575-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
  • Z-0580-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
  • Z-0571-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
  • Z-0574-2021 · Nov 19, 2020 · Terminated
    DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S

…and 3 more.

Other REAMER devices

All REAMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.