RECLAIM 2975-00-720Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295156093), received between Oct 18, 2017 and May 13, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Material Deformation

  IT WAS REPORTED THAT THE ROD FOR MODULAR RECLAIM DISASSEMBLY IS BENT. IT DID NOT HAPPENED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161261 ↗
• MalfunctionMay 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENTS BROKE DURING EXPLANT. THE PROXIMAL BODY OF RECLAIM WAS COLD WELDED ONTO THE DISTAL STEM. THE DISTAL STEM DID NOT COME OUT. PATIENT WAS NOT HARMED. NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148563 ↗
• MalfunctionAug 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT HAS A RIGHT TOTAL HIP THAT IS INFECTED. IT IS UNKNOWN WHEN THE HIP WAS DONE. THE SURGEON REMOVED ALL COMPONENTS. THE RECLAIM DISASSEMBLY TOOL WAS NOT ABLE TO SEPARATE THE PROXIMAL BODY FROM THE DISTAL STEM. THE ROD THAT SEPARATES THE TAPER BENT, AND THE DEVICE THAT ATTACHES TO THE SHOULDER OF THE PROXIMAL BODY BROKE AT THE ATTACHMENT POINT. THE SURGEON PUT EXTREME PRESSURE ON THE TOOL AND IT STILL WOULD NOT SEPARATE THE BODY FROM THE STEM. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819584 ↗
• MalfunctionJun 16, 2025Break; Break

  DISASSEMBLY INSTRUMENTS BROKE WHEN ATTEMPTING TO BREAK THE TAPER OF THE REMOVED RECLAIM STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212779 ↗
• MalfunctionJan 2, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT 85MM TORQUE SHAFT AND PUSHROD WERE COLD WELDED (INSEPARABLE). THE PUSHROD TIP WAS BENT. THE BODY COLLET EXPANSION TIPS SHEARED OFF(FRAGMENTS WERE DISPOSED OF BY FACILITY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056476 ↗
• MalfunctionAug 21, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING REVISION THE MODULAR RECLAIM TO BE DISASSEMBLED, FOLLOWED THE SURGICAL TECHNIQUE IN ORDER TO DISASSOCIATE THE PROXIMAL BODY FROM THE DISTAL STEM, THE DISASSEMBLY CLAMP TABS WERE DESTROYED TRYING TO TURN DOWN THE PROPERLY ASSEMBLED DISASSEMBLY TOOL. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023564 ↗
• MalfunctionOct 25, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE ATTEMPTING TO DISASSEMBLE A RECLAIM THE INNER ROD SNAPPED INTO THE BLUE 75 THREADED PIECE AND THE LOCKING FLOWER MECHANISM AT THE END CONTORTED. GOT STUCK IN THE PROXIMAL BODY WITHOUT BREAKING THE TAPER. WE GOT THE DISASSEMBLY DEVICE OUT WITH THESE 3 PIECES BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18001968 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FRILLS ON BOTH COLLETS SNAPPED OFF WHILE ATTEMPTING TO BREAK TAPER ON STEM. KNURLED SLEEVE ON DISASSEMBLY TOOL BODY IS STRIPPED. PUSH ROD AND 75MM TORQUE SHAFT ARE ESSENTIALLY WELDED TOGETHER. EXTREMELY DIFFICULT TO SEPARATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590510 ↗
• MalfunctionJun 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  RECLAIM DISASSEMBLY TOOL WAS DAMAGED DURING PROXIMAL BODY EXTRACTION. THE TEETH WERE SHEERED OFF AND THREE PIECES ARE NOW STUCK TOGETHER. WE WERE UNABLE TO REMOVE PROXIMAL. ALL BROKEN PIECES WERE RETRIEVED AS FAR AS WE COULD TELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828305 ↗
• MalfunctionJun 22, 2022Break; Break

  INSTRUMENTS WERE DAMAGED DURING SURGERY. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14773772 ↗
• MalfunctionJan 25, 2022Material Deformation; Material Deformation

  IT WAS REPORTED AS NO PATIENT AND NO SURGERY. GOING THROUGH INSTRUMENT PANS AND FOUND ITEM TO BE BENT ON BOTH ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342027 ↗
• MalfunctionJan 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  INSTRUMENTS WOULD NOT COME APART AFTER SURGERY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193541 ↗
• MalfunctionNov 9, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PUSH ROD TIP WAS BENT, FORCED INTO TRQ SHFT 95, AND NOW STUCK TOGETHER. LOCKING TIP MISSING FROM BODY COLLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779229 ↗
• MalfunctionSep 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN TRYING TO BREAK THE TAPER OF THE STEM WITH THE DISASSEMBLY INSTRUMENTS, THE DISASSEMBLY COLLET BROKE, AND THE CAP, PUSH ROD AND TORQUE SHAFT ALL BECAME COLD WELDED INTO EACH OTHER. THEY OPENED AN ADDITIONAL SET, AND THE SAME THING OCCURRED WHERE THE COLLET BROKE, BUT THE OTHER ITEMS DIDN'T COLD WELD THE SECOND TIME. WITH A SURGICAL DELAY OF 10 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12491233 ↗
• MalfunctionJul 7, 2021Break; Break

  IT WAS REPORTED THAT THE RECLAIM DISASSEMBLY TOOL BROKEN. ADDITIONALLY, THE TIP OF AN INTERNAL ROD BROKE. ALSO, THE TIP OF 75MM BOLD BROKE AND IS STUCK IN REMOVAL COLLAR. ALL PIECES REMOVED FROM PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131346 ↗
• MalfunctionMay 26, 2021Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED AS "INSTRUMENTS COLD WELDED, STRIPPED, OR BENT DURING STEM EXTRACTION. PIECES CAN NOT BE SEPARATED FOR REUSE. NO INSTRUMENT BROKE INTO PIECES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887045 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT THE HEAD WAS REVISED FOR INFECTION. ATTEMPTS WERE MADE TO REVISE RECLAIM PROXIMAL BUT THE DISASSEMBLY TOOL BROKE IN DIFFERENT PIACES. NO PIECES WERE LEFT IN THE PATIENT. SURGERY TIME WAS EXTENDED FOR 1 HR. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11813809 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT THE HEAD WAS REVISED FOR INFECTION. ATTEMPTS WERE MADE TO REVISE RECLAIM PROXIMAL BUT THE DISASSEMBLY TOOL BROKE IN DIFFERENT PIACES. NO PIECES WERE LEFT IN THE PATIENT. SURGERY TIME WAS EXTENDED FOR 1 HR. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11813805 ↗
• MalfunctionDec 14, 2020Break; Break

  IT WAS REPORTED THAT ALL REPORTED INSTRUMENTS BROKE IN SURGERY. ALL PIECES RETRIEVED FROM THE PATIENT. EVENT DID NOT DELAY THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11004491 ↗
• MalfunctionAug 14, 2020Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS BROKE WHILE TRYING TO DISENGAGE PROXIMAL BODY. THERE WAS AN (1) ONE HOUR OF SURGICAL DELAY.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10410762 ↗
• MalfunctionMay 28, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD A SMALL FRACTURE IN THE PROXIMAL FEMUR AND SO THE SURGEON PLANNED TO UP-SIZE THE RECLAIM PROXIMAL BODY AND CABLE THE FRACTURE. SURGEON TRIED TO DISENGAGE THE TAPER OF THE RECLAIM PROXIMAL BODY, BUT THE TAPER WAS COLD WELDED TOGETHER AND UNABLE TO SEPARATE IT FROM THE DISTAL STEM. IN THE PROCESS OF TRYING TO SEPARATE THE IMPLANTS, THE PUSH ROD BENT AND DAMAGED THE 95MM TORQUE SHAFT. SINCE THE SURGEON WAS UNABLE TO SEPARATE THE TAPER, HE DECIDED TO LEAVE THE STEM IN PLACE AND ONLY REPLACE THE HEAD AND LOCKING BOLT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10099384 ↗
• MalfunctionMay 20, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD A RECLAIM HIP REVISION APPROXIMATELY 6 YEARS AGO. PATIENT BECAME INFECTED AND DURING REVISION THE PROXIMAL BODY COULD NOT BE DISASSOCIATED FROM THE DISTAL STEM. THE DISASSEMBLE ROD WAS BENT WHILE ATTEMPTING TO DISASSEMBLE. IT WAS NOT KNOWN IF THIS PIECE WAS BENT PRIOR TO THE CASE OR NOT.

  Patient problems: Not Applicable

  MAUDE report 10076808 ↗
• MalfunctionDec 4, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE SCRUB TECH WAS TRYING TO GRIP THE IMPLANT WITH THE DISASSEMBLY TOOL AND THE TOOL WAS NOT GRIPPING (HOLDING ONTO) THE IMPLANT CORRECTLY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 10. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9411660 ↗
• MalfunctionOct 11, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT BOTH ENDS OF ROD SLIGHTLY BENT. NO DELAY OF CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9181421 ↗
• MalfunctionSep 12, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE RECLAIM DISASSEMBLY TOOL DID NOT WORK. PUSH ROD BENT UNDER LOAD. PROXIMAL BODY DID NOT DISENGAGE. THERE WAS A 15-20 MINUTES SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9010135 ↗