RECLAIM 2975-00-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295155942), received between Oct 24, 2017 and Mar 3, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (14 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Device-Device Incompatibility

  AFTER THE SURGERY WAS COMPLETED, WHEN THE EQUIPMENT WAS ORGANIZED AND LEFT READY FOR FURTHER COLLECTION, IN THE INSTRUMENT (EQUIPMENT NO. 41025736), WHEN THE PIECE REF D297500600 WAS DISASSEMBLED, IT WAS BLOCKED AND COULD NOT BE SEPARATED. FOR THIS REASON, IT WAS MARKED WITH RED TAPE AND LEFT TOGETHER WITH THE REST OF THE TEAMS, SO THAT, WHEN THEY ARE RETURNED TO J&J, IT IS EASY TO IDENTIFY AND PROCEED TO ITS REVIEW AND DISASSEMBLY. NO DISCOMFORT WAS RECORDED ON THE PART OF THE SPECIALIST, SINCE THE SURGERY HAD CONCLUDED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498345 ↗
• MalfunctionOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT NOTHING BROKE SPECIFICALLY, JUST STUCK TOGETHER. INSTRUMENTS CANNOT BE USED IF NOT TAKEN A PART SO THEY WERE TAKEN OUT OF THE ROTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392124 ↗
• MalfunctionSep 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY. THE ASSEMBLY TOOL AND ASSEMBLY PULL ROD KEPT COMING APART WHEN TRYING TO BE USED DURING SURGERY, AND THEN WOULDN¿T COME APART AFTER THE CASE; BELIEVED TO BE CROSS THREADED. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004343 ↗
• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE ASSEMBLY TOOL ADAPTERS DID NOT CONNECT TO THE RECLAIM ASSEMBLY BODY. THE SURGICAL DELAY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872999 ↗
• MalfunctionJun 25, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT TFN REMOVED AND IMPLANTED THE RECLAIM STEM. RECLAIM ASSEMBLY BODY AND RECLAIM ASSEM UPPER PULL ROD WERE REPORTED FOR UNKNOWN REASON. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT RECLAIM ASSEM UPPER PULL ROD WAS RETURNED ASSEMBLE TO THE RECLAIM ASSEMBLY BODY. A FUNCTIONAL TEST WAS PERFORMED AND REVEALED THAT THE RECLAIM ASSEMBLY BODY IS JAMMED AND WILL NO LONGER SPIN UP AND DOWN THE THREADS THROUGH THE RETURNED MATING DEVICE. THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604481 ↗
• MalfunctionApr 18, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ASSEMBLY TWO PIECE DEVICE WOULD NOT THREAD. THIS DID NOT SLOW THE CASE DOWN SINCE THERE WAS A BACKUP AND PROCEDURE PROCEEDED LIKE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130342 ↗
• MalfunctionNov 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ASSEMBLY TOOL PULL ROD GOT STUCK IN THE ASSEMBLY TOOL DURING INSERTION OF THE PROXIMAL BODY.

  Patient problems: Insufficient Information

  MAUDE report 18226727 ↗
• MalfunctionJun 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE FITS SUPER TIGHT WITH ANOTHER PIECE THAT IS INTENDED TO MAKE THE TORQUE WITH THE SAND WATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097889 ↗
• MalfunctionJan 13, 2023Break; Break

  IT WAS NOTICED THAT THE METAL AND RUBBER PIECES WERE OFF OF INSERTION HANDLE DURING TRAY SETUP. IT DID NOT HAPPEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157722 ↗
• MalfunctionDec 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ASSEMBLY TOOL THREADS GOT LOCKED IN PLACE AND HAD TO REVERSE TO GET IT OUT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928828 ↗
• MalfunctionDec 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INTERNAL ASSEMBLY ROD IS STUCK INTO HOUSING AND WILL NOT UNSCREW FROM HOUSING. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927133 ↗
• MalfunctionJun 20, 2022Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn

  IT WAS REPORTED THAT ONCE THE RECLAIM DISTAL STEM WAS IMPLANTED AND SEAT THE PROXIMAL BODY, HE WENT TO TIGHTEN THE TOP KNOB ON THE TENSILE BAR TORQUE LIMITER AND HE WAS UNABLE TO TWIST THE KNOB WITH THE HELICOPTER BAR. UPON DISASSEMBLY OF THE INSTRUMENT WE DETERMINED THAT THERE WAS AN ISSUE WITH THE THREADING ON THE TOP NUT AND IT WAS IMPOSSIBLE TO TURN. NOTHING WAS LOST OR BROKEN IN THE CASE, THE INSTRUMENT WILL BE SEND BACK IN ITS ENTIRETY FOR REPLACEMENT. THERE WAS NO HARM DONE TO THE PATIENT, AND ONLY MINIMAL DELAY IN THE PROCEDURE (<5 MINUTES). THE SALES REP HAVE NO FURTHER INFORMATION REGARDING THIS SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742843 ↗
• MalfunctionApr 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  FOLLOWING A RECLAIM REVISION HIP OPERATION WITH THE SURGEON YESTERDAY, HE WANTED TO GO THROUGH THE BUILDING AND USE OF THE RECLAIM ASSEMBLY TOOL AT THE END OF THE CASE, ONCE THE OPERATION WAS COMPLETED. HAVING REBUILT THIS USING THE OUTER HOUSING AND TORQUE INNER ASSEMBLY, I WENT THROUGH THE PROCESS WITH HIM. ONCE WE FINISHED THE RUN THROUGH, WE COULD NOT REMOVE THE INNER TORQUE ASSEMBLY FROM THE OUTER HOUSING. IT WAS WELL AND TRULY STUCK. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160241 ↗
• MalfunctionMar 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DURING THE SURGICAL PROCEDURE, WHEN AN ATTEMPT WAS MADE TO ATTACH THE METAPHYSIS TO THE STEM, THE ADAPTER DID NOT GRIP THE STEM WELL AND THE ASSEMBLY PIECE FROZE AND DID NOT ROTATE IN ANY DIRECTION. NO REPORTED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13889528 ↗
• MalfunctionFeb 15, 2022Device-Device Incompatibility; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, WHEN AN ATTEMPT WAS MADE TO ATTACH THE METAPHYSIS TO THE STEM, THE ADAPTER DID NOT GRIP THE STEM WELL AND THE ASSEMBLY PIECE FROZE AND DID NOT ROTATE IN ANY DIRECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13533689 ↗
• MalfunctionFeb 2, 2022Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn

  THE HOSPITAL HAVE REPORTED INSTRUMENTS THAT ARE NEEDING REPLACEMENT DUE TO WEAR AND TEAR.

  Patient problems: Insufficient Information

  MAUDE report 13424712 ↗
• MalfunctionNov 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  INTRAOPERATIVELY THE INSTRUMENT FRACTURED. SURGERY DELAY ABOUT 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12778539 ↗
• MalfunctionJul 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ARE CROSS THREADED AND ARE NOT ALLOWING THE PULL BAR TO ENGAGE CORRECTLY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246463 ↗
• MalfunctionMar 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE SURGEON SAID THAT THE PATIENT IS DOING WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592645 ↗
• MalfunctionAug 31, 2020Break; Device-Device Incompatibility; Mechanical Jam; Physical Resistance/Sticking; Break; Device-Device Incompatibility; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE RECLAIM ASSEMBLY TOOL FOR PLACING 2000 PSI GOT STUCK IN IMPLANT AFTER THE TENSILE BAR APPROPRIATELY BROKE. HAD TO TAKE OUT ENTIRE CONSTRUCT. SURGICAL DELAY OF ONE HOUR REPORTED.

  Patient problems: No Code Available

  MAUDE report 10470873 ↗
• MalfunctionDec 7, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  INSTRUMENTS WAS UNABLE TO DISASSEMBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8142613 ↗
• MalfunctionAug 7, 2018Break; Break

  THE TIP BROKE DUE TO BAD EFFORT OR SYSTEM FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7756219 ↗
• MalfunctionApr 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE GUIDE POST WOULDN¿T PROPERLY THREAD INTO THE DISTAL RECLAIM STEM, AND THE SURGEON FELT IT DAMAGED THE THREADS INSIDE THE STEM. THE ASSEMBLY TOOL ALSO WOULDN¿T THREAD INTO THE DISTAL STEM PROPERLY, SO THE SURGEON DECIDED TO PUT IN A NEW DISTAL STEM. THE 18X140 WAS COMPROMISED AND COULDN¿T BE USED. NO SURGICAL DELAY.

  Patient problems: Insufficient Information; No Code Available; Not Applicable

  MAUDE report 7424733 ↗
• MalfunctionJan 23, 2018Break; Break

  IT WAS REPORTED THAT THE SURGEON BROKE THE INSTRUMENT DURING USE. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7212122 ↗
• MalfunctionOct 24, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PISTON ROD GOT STUCK IN THE ASSEMBLY TOWER. THEY COULDN'T GET IT APART POST SURGERY, MAYBE IT'S CROSS THREADED.

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

  MAUDE report 6971261 ↗