RECLAIM 40-00000-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295534976), received between Jan 27, 2025 and Sep 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740513 ↗
• MalfunctionJun 17, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INSERTER WOULD NOT HOLD THE STEM FLUSH TO THE INSERTION HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534075 ↗
• MalfunctionApr 16, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE ISSUE WAS NOTICED WHEN RESETTING A TRAY. THE THREADS ARE STRIPPED AND WILL NO LONGER THREAD INTO THE STEM INSERTION INSTRUMENTATION. THIS DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894329 ↗
• MalfunctionApr 8, 2026Material Deformation

  IT WAS DISCOVERED DURING THE CASE THAT THE THREADS ON THE STEM INSERTER WERE STRIPPED. THERE WAS NO DELAY ENCOUNTERED AS THE OTHER IMPACTOR WAS USED IN THE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820689 ↗
• MalfunctionApr 7, 2026Material Deformation

  IT WAS REPORTED THAT THE THREADS ON THE RCLM MON STEM INSERTER-LOCATOR WERE ALL BENT. THE EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24803206 ↗
• MalfunctionMar 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT IMPACTOR THREADS WOULD NOT THREAD INTO THE IMPLANT. IT DID NOT DELAY THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499242 ↗
• MalfunctionOct 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE RECLAIM MONOBLOC STEM INSERTER LOCATOR WAS CROSS THREADED AND WAS UNABLE TO ENGAGE THE INSERTER WITH THE STEM DURING IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348674 ↗
• MalfunctionFeb 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADED PART OF THE INSERTER/LOCATOR WAS STRIPPED WHERE IT CONNECTS TO THE IMPLANT. THIS WAS NOTICED WHILE CHECKING TRAYS AT THE WAREHOUSE FOR AN UPCOMING SURGERY. A NEW ITEM WAS ORDERED TO REPLACE IT. THERE WAS NO KNOWN COMPLICATION TO ANY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405245 ↗
• MalfunctionJan 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS ARE DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 21245876 ↗