RECLAIM 2975-00-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295155966), received between Aug 25, 2017 and Dec 15, 2023 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

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

• MalfunctionDec 15, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE SURGICAL CASE THE TECH WAS ATTACHING THE ASSEMBLY ADAPTOR TO THE ASSEMBLY TOOL HOUSING. IT WAS JUST FALLING OFF, AFTER LOOKING AT IT THE INNER SPRING WAS NOT IN PLACE. THE CASE WAS NOT DELAYED AND NO PARTS WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334162 ↗
• MalfunctionSep 7, 2023Structural Problem; Material Integrity Problem; Structural Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SPRING INSIDE THE 85 MM ADAPTER FOR THE RECLAIM ASSEMBLY TOOL WAS DAMAGED. IT IS NOT ABLE TO CONNECT TO THE RECLAIM ASSEMBLY TOOL. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? -- NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? -- NO, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS?-- NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES -- NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?-- NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: -- NO, IS THE PATIENT PART OF A CLINICAL STUDY -- UNKNOWN, IP- (B)(4). DEVICE PROPERTY OF -- OTHER, DEVICE IN POSSESSION OF --1 BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.-- TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697691 ↗
• MalfunctionJul 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TORQUE WRENCH BODY AND T-HANDLE CONNECTION WERE STRIPPED. ASSEMBLY TOOL ADAPTERS ARE NOT BEING RETAINED ON THE HOUSING. REAMER EXTRACTOR ADAPTER IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398353 ↗
• MalfunctionJan 19, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE SPRING WAS FOUND TO BE BROKEN AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16204350 ↗
• MalfunctionOct 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INSERTION PIECE WILL NOT SNAP INTO PLACE ON THE INSTRUMENT USED TO ENGAGE THE PROXIMAL BODY TO THE DISTAL STEM. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15589029 ↗
• MalfunctionJun 22, 2022Break; Break

  ADAPTER IS MISSING INSIDE SPRING. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14774513 ↗
• MalfunctionMar 26, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING WAS NOTICED MISSING FROM PROXIMAL ASSEMBLY GUIDE AFTER GOING THROUGH THE DECONTAMINATION PROCESS. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13919687 ↗
• MalfunctionSep 24, 2021Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  PRIOR TO SURGERY WHEN RUNNING THROUGH INSTRUMENTS - NOTICED THAT 85MM ADAPATER DID NOT HAVE THE INTERNAL SPRING, CAUSING IT TO BECOME DISENGAGED FROM ASSEMBLY TOOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526610 ↗
• MalfunctionAug 2, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PULL BAR HAS BENT AT THE TOP ATTACHMENT UNDER THE THREADS. IT APPEARS NOT TO BE STRAIGHT IN LINE ANYMORE AND IS BENT OUTWARDS QUITE A BIT. THE 28 HEAD TRIAL IS MISSING A PIECE OF MATERIAL AT THE NECK JUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12262210 ↗
• MalfunctionJul 30, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE HANDLE AND PRONG ON THE BODY ARE NOT LOCKING TOGETHER CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252916 ↗
• MalfunctionJun 16, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  TWO OF THE PARTS FOR THE RECLAIM CONSIGNMENT SET ON SHELF ARE TIRED AND NEED REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011724 ↗
• MalfunctionFeb 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREADS ON PULL ROD ARE STRIPPED. NOTICED IN SPD SO WASN¿T T USED ON A CASE YET. 85 AND 105 ADAPTERS HAVE THE LOCKING SPRINGS AND THEY ARE BENT AND DAMAGED. NO SURGICAL DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343233 ↗
• MalfunctionJul 15, 2020Break; Fracture; Device-Device Incompatibility; Break; Fracture; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPRING DAMAGED, NOT ALLOWING ADAPTER TO LOCK ON. 2 PIECES , BOTH RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10275951 ↗
• MalfunctionJan 23, 2020Component Missing; Material Twisted/Bent; Component Missing; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT IT APPEARS THE LOCKING MECHANISM INSIDE THE ADAPTOR WAS STRIPPED, HAD NO BEARINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9619784 ↗
• MalfunctionNov 5, 2019Material Deformation; Material Deformation

  BAL SEAL HAS BEEN DAMAGED. DAMAGED BAL SEALS ARE BEING RETURNED. THE ASSEMBLY TOOL BODY IS NOT BEING RETURNED, AS THE BAL SEALS HAVE BEEN REPLACED. THEY HAVE BEEN REPLACED WITH BAL SEALS X574850 AS PER DRAWING ATTACHED TO THIS PRODUCT COMPLAINT FORM. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279377 ↗
• MalfunctionAug 13, 2019Break; Material Fragmentation; Break; Material Fragmentation

  SPRING INSIDE THE BODY HAS BROKE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889315 ↗
• MalfunctionMay 28, 2019Break; Break

  IT WAS REPORTED WHILE INSPECTING THE INSTRUMENTS PRIOR TO STERILIZATION, IT WAS FOUND THAT THE SPRING WAS DAMAGED ON THE ADAPTER FOR THE ASSEMBLY TOOL. THE INSTRUMENT WAS NOT USED IN SURGERY. SURGERY WAS NOT EXTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8647206 ↗
• MalfunctionMay 21, 2019Break; Component Missing; Device-Device Incompatibility; Break; Component Missing; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INNER SPRING ON ADAPTER HAD SEPARATED FROM THE INNER RIM OF ADAPTER PREVENTING IT FROM ENGAGING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628231 ↗
• MalfunctionJul 23, 2018Break; Break

  IT WAS REPORTED THAT THE SPRING CAME OUT OF THE 85MM RECLAIM INSTRUMENT. IT WAS RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7709896 ↗
• MalfunctionFeb 9, 2018Component Missing; Component Missing

  THE CADDY THAT HOUSES THE RECLAIM REAMERS IS MISSING A SCREW AND WON'T OPEN PROPERLY. IN ADDITION, THE ASSEMBLY TOOL ADAPTOR (85) IS MISSING A SPRING AND NEEDS TO BE REPLACED. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7258732 ↗
• MalfunctionDec 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE TOOL ADAPTER HAD A BROKEN SPRING IN ASSEMBLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7113139 ↗
• MalfunctionAug 25, 2017Bent; Bent

  IT WAS REPORTED THAT WHILE PREPARING FOR A CASE THE SPRING INSIDE THE 85 MM ASSEMBLY TOOL ADAPTOR WAS BENT, PREVENTING IT FROM SNAPPING ONTO THE RECLAIM ASSEMBLY TOOL. THE CASE WAS RESCHEDULED THE NEXT DAY AND WAS ABLE TO GET A REPLACEMENT INSTRUMENT TO USE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6820521 ↗
• MalfunctionAug 25, 2017Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN SPRING IN INSERTION TOOL ADAPTER. THIS WAS NOT FOR A PROCEDURE, BUT WAS NOTICED UPON RECEIPT OF INSTRUMENTS FROM ANOTHER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 6820064 ↗