RECLAIM 2975-00-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295156079), received between Mar 14, 2019 and May 12, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 25148564 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TAPER OF STEM BROKE. DISASSEMBLY JIG COLD THREADED-UNABLE TO UNSCREW. NO PARTS LEFT BEHIND. NO LOOSENING, ALL PIECES RETRIEVED FROM PATIENT. NO DELAY. NO OTHER INFORMATION KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20522372 ↗
• 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 14828302 ↗
• MalfunctionOct 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ASSEMBLY THREADED CAP WOULD NOT UNSCREW FROM THE TORQUE SHAFT. THE BODY COLLET WAS BROKEN DURING ATTEMPTED EXTRACTION OF PROXIMAL BODY. THE BODY COLLET WOULD NOT COME APART FROM THE DISASSEMBLY BODY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699384 ↗
• 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 12491213 ↗
• MalfunctionJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSTRUMENTS WERE USED DURING SURGERY WITH NO ISSUES. ISSUE WAS FOUND WHILE SETTING TRAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240732 ↗
• 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 12131348 ↗
• 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 11887047 ↗
• 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 11813755 ↗
• 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 10410764 ↗
• MalfunctionAug 10, 2020Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  (B)(6) HOSPITAL, THE INSTRUMENT FLAGGED AS THREADED BY THE CUSTOMER. SET NUMBER: ZZINAUH0612.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10384933 ↗
• MalfunctionJan 23, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE 85 MM ASSEMBLY ROD ADAPTOR IS MISSING LOCKING BEARINGS. 75MM, 85MM, AND CAP DO NOT SCREW TOGETHER PROPERLY, NEED NEW PRODUCTS FOUND DEFECTIVE DURING TRAINING IN OFFICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9619781 ↗
• 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 9411881 ↗
• MalfunctionMay 30, 2019Device-Device Incompatibility; Material Twisted/Bent; Physical Resistance/Sticking; Device-Device Incompatibility; Material Twisted/Bent; Physical Resistance/Sticking

  THERE IS A COMBINATION OF FOUR INSTRUMENTS THAT WERE DAMAGED DURING THIS CASE. IT WAS DISCOVERED THAT THESE ITEMS WERE DAMAGE WHILE PUTTING THEM BACK TOGETHER IN STERILE PROCESSING FOLLOWING THE CASE. THERE WERE NO DELAYS DURING THE ACTUAL CASE. THE FIRST TWO INSTRUMENTS THAT WERE DAMAGED OR THE DISASSEMBLY A TOOL THREADED CAP, AND THE DISASSEMBLE A TORQUE SHAFT 75 MM. THERE IS A THREAD ON THE THREADED CAP THAT IS STRIPPED AND THE 75 MM TORQUE SHAFT CANNOT BE REMOVED FROM THE THREADED CAP. THE SECOND SET OF INSTRUMENTS THAT WERE DAMAGED THAT WORK TOGETHER OR THE BOLT TORQUE WRENCH HANDLE IN THE BOLT TORQUE WRENCH BODY. THE T HANDLE THAT ATTACHES TO THE BOLT TORQUE WRENCH HANDLE BROKE OFF OF THAT DEVICE AND CANNOT BE FOUND IN STERILE PROCESSING. HOWEVER, THERE IS STILL A PORTION OF THE BOLT TORQUE WRENCH HANDLE THAT IS ATTACHED TO THE BOLT TORQUE WRENCH BODY AND CANNOT BE REMOVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655302 ↗
• MalfunctionMar 14, 2019Difficult to Remove; Fitting Problem; Connection Problem; Material Deformation; Difficult to Remove; Fitting Problem; Connection Problem; Material Deformation

  UPON ROUTINE INSPECTION OF THE RECLAIM DISASSEMBLY INSTRUMENT SET, I NOTICED THAT THE THREADED CAP WAS DAMAGED AND WOULD NOT THREAD INTO THE DISASSEMBLY BODY. UPON INSPECTION, I NOTICED THAT ONE OF THE THREADS IS DAMAGED AND THAT THERE IS A SHARP METAL EDGE THAT IS PROTRUDING AND PREVENTING THE CAP FROM BEING TIGHTENED ON TO THE DISASSEMBLY BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420003 ↗