RECLAIM 2975-00-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10603295156161), received between Aug 29, 2017 and May 26, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (17 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Break

  IT WAS FOUND OUT THAT THE DEVICE WAS BROKEN WHEN CHECKING THE TRAY BEFORE GOING OUT TO SURGERY. IT DID NOT HAPPENED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25277637 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT THE RUBBER GRIP OF THE RECLAIM DISTAL STEM INSERTER DEVICE WAS TORN APART DURING USE. UNABLE TO BE PROPERLY STERILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384392 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN UPON ARRIVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853800 ↗
• MalfunctionNov 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A HIP SURGERY, IT WAS OBSERVED THAT THE STEM INSERTER HAD TROUBLE THREADING ONTO THE DISTAL STEM. THREADS LOOK A LITTLE BEAT UP FROM USE. ACTIVITY LEVEL - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597239 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT. WHEN THIS INSTRUMENT CAME IN, IT WAS BROKEN RIGHT OUT OF THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025359 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT WHEN CLEANING THE INSTRUMENT, STAFF BECAME AWARE THAT THE TREADS ON INSERTER WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22013267 ↗
• MalfunctionApr 28, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS ARE WORN AND CROSS THREAD ON THE INSERTER HANDLE. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922677 ↗
• MalfunctionMar 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT RECLAIM STEM WAS REMOVED, UPON TRAY ASSEMBLY AND INSPECTION THE SLAP HAMMER AND RECLAIM STEM HANDLE WERE VISIBLY CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647605 ↗
• MalfunctionMar 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREAD AT THE DISTAL END OF THE INSERTER WHICH SCREWS INTO THE IMPLANT SHEERED BUT WAS ABLE TO COMPLETE SURGERY. IT IS NOW UNUSABLE. THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606274 ↗
• MalfunctionJan 11, 2024Naturally Worn; Naturally Worn

  DAMAGE TO END OF DISTAL STEM. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495899 ↗
• MalfunctionDec 11, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED. A. DID THE INSTRUMENT BREAK INTO 2 OR MORE PIECES? NO. B. DID THIS OCCUR INTRA-OP? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302062 ↗
• MalfunctionNov 13, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT WHILE IMPACTING DISTAL STEM, WOBBLED ON THE DISTAL STEM INSERTER. SURGEON SAID CAME LOOSE. IT WAS UNKNOWN ABOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118342 ↗
• MalfunctionNov 6, 2023Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT STEM INSERTER WAS CRACKING WHERE THE METAL MEETS THE RUBBER HANDLE, MUST BE FROM HITTING IT WITH MALLET WHEN INSERTING DISTAL STEM. NO SURGICAL DELAY. THESE INSTRUMENT MALFUNCTIONS AND REPAIR NEEDS WERE NOTICED AFTER THE SURGERY, WHEN RESETTING THE TRAYS FOR UPCOMING CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075101 ↗
• MalfunctionJul 31, 2023Break; Break

  IT WAS REPORTED THAT THE RECLAIM STEM INSERTER HANDLE HAS THE PLASTIC PEELING OFF THE TOP ALONG WITH SOME METAL SHAVINGS. THE HOSPITAL WOULD NOT LET THE INSTRUMENT TO BE USED BECAUSE THEY WERE CONCERNED OF BIOFILM WITHIN THE PLASTIC PEELING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424917 ↗
• MalfunctionMay 30, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECLAIM DISTAL STEM INSERTER IS MISSING 1 PART OF 2 PARTS WHICH PREVENTED SCREWING INSERTER INTO DISTAL STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020772 ↗
• MalfunctionMay 12, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ON THE DISTAL STEM INSERTER STRIPPED.

  Patient problems: Insufficient Information

  MAUDE report 16920166 ↗
• MalfunctionMay 12, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ON THE DISTAL STEM INSERTER STRIPPED.

  Patient problems: Insufficient Information

  MAUDE report 16920154 ↗
• MalfunctionApr 26, 2023Break; Break

  THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815183 ↗
• MalfunctionApr 24, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING THE REVISION OF HIP, INSTRUMENT NOT USED BUT NOTICED THREADS OF THE INNER THREADED SHAFT WERE COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795086 ↗
• MalfunctionJan 18, 2023Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE GRIP OF DISTAL STEM INSERTER WAS DAMAGED. THIS EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196459 ↗
• MalfunctionDec 16, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THREADS WERE CROSS THREADED AND NEED NEW HANDLE. ALL PARTS WERE RECOVERED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996256 ↗
• MalfunctionSep 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECLAIM INSERTION HANDLE WOULD NOT FULLY SEAT ONTO RECLAIMS. THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF LESS THAN TWO MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 15360308 ↗
• 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 15209813 ↗
• MalfunctionJul 22, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ON THE STEM INSERTER STRIPPED. THERE WAS A SURGICAL DELAY OF 10 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 15084305 ↗
• MalfunctionMay 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECLAIM STEM INSERTER THREADS WOULD NOT ENGAGED AND WE HAD TO USE A BACK UP CONICAL CORE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270115 ↗