RECLAIM 2975-00-910Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295156185), received between Jan 5, 2018 and Apr 23, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Material Deformation

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE HIP IT WAS OBSERVED THAT THE NECK TRIAL AND STEM EXTRACTOR WERE STRIPPED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971501 ↗
• MalfunctionFeb 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HEX DRIVER WAS STRIPPED, NEEDING REPLACEMENT. THE INSERTER WAS STRIPPED AS WELL.

  Patient problems: Insufficient Information

  MAUDE report 21347113 ↗
• MalfunctionJan 11, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENT BECAME CROSS THREADED DURING NORMAL USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11147753 ↗
• MalfunctionOct 12, 2020Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10667130 ↗
• MalfunctionJun 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DURING HIP REVISION SURGERY AT (B)(6) HOSPITAL ON MONDAY (B)(6) 2020 IT WAS NOT POSSIBLE TO SEPARATE THE FOLLOWING TWO RECLAIM INSTRUMENTS AFTER THEY HAD BEEN USED TO REMOVE A DISTAL REAMER. SURGEON WAS MR (B)(6). 297500800 RECLAIM DISTAL STEM INSERTER, LOT SO2034382; 297500910 RECLAIM REAMER EXTRACT ADAPTOR, LOT SO2042156. AFTER APPROXIMATELY 10 MINUTES OF TRYING TO SEPARATE THE INSTRUMENTS THE SURGEON GAVE UP AND HAD TO COMPLETE THE REST OF THE OPERATION WITHOUT THE DISTAL STEM INSERTER.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10111387 ↗
• MalfunctionSep 14, 2018Mechanical Jam; Mechanical Jam

  DAMAGED INSTRUMENTS: EXTRACTOR THREAD COLD WELDED TO THE INTRODUCER HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877864 ↗
• MalfunctionSep 10, 2018Corroded; Corroded

  CUSTOMER REPORTS THAT THEY RECEIVED A SECOND ENTIRE HIP SET WITH RUST ON ALMOST EVERY PART OF THE KIT ON (B)(6) (THIS 2ND KIT WAS SENT TO REPLACE THE FIRST ONE SENT ON AND RECEIVED ON (B)(4). THIS KIT WENT TO CUSTOMER ON (B)(6) 2017 AND WAS NEW AT THE TIME (1ST USE), IT CAME BACK TO ST PRIEST AND WAS CHECKED ON (B)(6) 2017. THEN IT GOES TO CUSTOMER ON (B)(6) THIS YEAR. IMPACTED PRODUCTS WILL BE FILLED IN WHEN WE WILL RECEIVED THE KIT BACK ON ST PRIEST. SEE PHOTOS ATTACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7859394 ↗
• MalfunctionJan 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE IS A REMOVAL OF RECLAIM HIP STEM. INSTRUMENTS WERE CROSS THREADED IN STEM IMPLANT. NEEDS REPLACING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167139 ↗