RECLAIM 2975-00-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295155850), received between Apr 12, 2018 and Jan 26, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Material Deformation

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE RECLAIM MODULAR INSTRUMENTS WERE STRIPPED OUT AND NON-FUNCTIONAL. THE SURGEON HAD TO TRIAL OFF REAL IMPLANTS. THERE WAS NO PATIENT HARM, BUT THE PROCEDURE WAS DELAYED BY NINETY MINUTES DUE TO THE INABILITY TO PROPERLY TRIAL AND STRUGGLE WITH THE INSTRUMENTS. ACTIVITY LEVEL ¿ YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182995 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 19268522 ↗
• MalfunctionDec 14, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ITEMS WILL NOT THREAD, SURGEON COMPLAIN ABOUT THREADS STRIPPING ON ALL ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983825 ↗
• MalfunctionDec 14, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ITEMS WILL NOT THREAD, SURGEON COMPLAIN ABOUT THREADS STRIPPING ON ALL ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983820 ↗
• MalfunctionAug 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN OFF TABLE DIRECT ANTERIOR TOTAL HIP THE ACTIS BROACH PERFORATED THE FEMORAL SHAFT, CAUSING A TROCH FRACTURE. THE DOCTOR ELECTED TO CABLE THE FEMUR AND SWITCH TO A RECLAIM STEM. THE INCISION WAS EXTENDED. THE EXPOSURE WAS MADE DIFFICULT DUE TO THE PATIENTS LARGE ABDOMEN. THE FEMUR WAS PREPPED WITH THE RECLAIM INSTRUMENTS AND A 15X140 STEM WAS PLACED. WHEN REMOVING THE STEM FROM THE INSERTER THE STEM THREADS WERE STRIPPED AND CROSS THREADED. MULTIPLE ATTEMPTS WHERE MADE TO ATTACH THE STEM EXTRACTOR WITH THE RECLAIM INSTRUMENTS AND A UNIVERSAL EXTRACTOR SET. THESE ALL FAILED. THE DOCTOR THEN ELECTED TO SEAT THE PROXIMAL BODY BUT WAS UNABLE TO THREAD THE ASSEMBLY TOOL INTO THE STEM. SURGEON ELECTED TO PLACE THE PROXIMAL BODY AND IMPACT IT MANUALLY. THE LOCKING BOLT WAS ATTEMPTED. IT WAS UNABLE TO THREAD INTO THE STEM. THE DOCTOR REQUESTED THAT ALL THE THREADED INSTRUMENTS THAT WERE USED BE REPLACED. SURGERY TIME WAS EXTENDED BY 2 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209841 ↗
• MalfunctionJan 11, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE RECLAIM DISTAL STEM INSERTER WAS CROSS THREADED. RECLAIM PROX REAMER GUIDE POST WAS CROSS THREADED. SURGICAL DELAY OF 3 MINUTES AND NEEDS REPLACEMENT. NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 13226213 ↗
• MalfunctionAug 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO PIECES BROKEN OFF FROM THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331601 ↗
• MalfunctionJan 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SEVERAL RECLAIM INSTRUMENTS WITH THREADS WERE DAMAGED DURING NORMAL USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11142667 ↗
• MalfunctionJan 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SEVERAL RECLAIM INSTRUMENTS WITH THREADS WERE DAMAGED DURING NORMAL USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141666 ↗
• MalfunctionJan 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SEVERAL RECLAIM INSTRUMENTS WITH THREADS WERE DAMAGED DURING NORMAL USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141646 ↗
• MalfunctionDec 12, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENTS WON¿T THREAD PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155025 ↗
• MalfunctionSep 6, 2018Break; Corroded; Material Discolored; Appropriate Device Problem Term/Code Not Available; Break; Corroded; Material Discolored; Appropriate Device Problem Term/Code Not Available

  AFTER RECEIVING 2 COMPLAINTS ABOUT A HIP KIT, ORTHOKIT MANAGER CHECKED THE BUILD 5 IN THE WAREHOUSE, AND SAW RUST ON ALMOST EVERY PART OF THE KIT. FOR SOME PARTS IT'S ALSO MISSING COLOR CODES (USUALLY RED, YELLOW, GREEN, BLUE). THIS KIT WENT TO A CUSTOMER IN (B)(6) 2016 AND WAS NEW AT THE TIME. IT WAS CHECKED WHEN IT CAME BACK IN 2016 AND WAS LET IN STORAGE SINCE THEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850156 ↗
• 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 7424706 ↗