RECLAIM 2975-00-725Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295156109), received between Oct 1, 2018 and Oct 25, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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.

• MalfunctionOct 25, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2023, WHILE ATTEMPTING TO DISASSEMBLE A RECLAIM THE INNER ROD SNAPPED INTO THE BLUE 75 THREADED PIECE AND THE LOCKING FLOWER MECHANISM AT THE END CONTORTED. GOT STUCK IN THE PROXIMAL BODY WITHOUT BREAKING THE TAPER. WE GOT THE DISASSEMBLY DEVICE OUT WITH THESE 3 PIECES BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18001964 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FRILLS ON BOTH COLLETS SNAPPED OFF WHILE ATTEMPTING TO BREAK TAPER ON STEM. KNURLED SLEEVE ON DISASSEMBLY TOOL BODY IS STRIPPED. PUSH ROD AND 75MM TORQUE SHAFT ARE ESSENTIALLY WELDED TOGETHER. EXTREMELY DIFFICULT TO SEPARATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590507 ↗
• MalfunctionOct 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ASSEMBLY THREADED CAP WOULD NOT UNSCREW FROM THE TORQUE SHAFT. THE BODY COLLET WAS BROKEN DURING ATTEMPTED EXTRACTION OF PROXIMAL BODY. THE BODY COLLET WOULD NOT COME APART FROM THE DISASSEMBLY BODY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699358 ↗
• MalfunctionJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSTRUMENTS WERE USED DURING SURGERY WITH NO ISSUES. ISSUE WAS FOUND WHILE SETTING TRAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240734 ↗
• MalfunctionJul 7, 2021Break; Break

  IT WAS REPORTED THAT THE RECLAIM DISASSEMBLY TOOL BROKEN. ADDITIONALLY, THE TIP OF AN INTERNAL ROD BROKE. ALSO, THE TIP OF 75MM BOLD BROKE AND IS STUCK IN REMOVAL COLLAR. ALL PIECES REMOVED FROM PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131335 ↗
• MalfunctionMay 26, 2021Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED AS "INSTRUMENTS COLD WELDED, STRIPPED, OR BENT DURING STEM EXTRACTION. PIECES CAN NOT BE SEPARATED FOR REUSE. NO INSTRUMENT BROKE INTO PIECES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887041 ↗
• MalfunctionJan 23, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE 85 MM ASSEMBLY ROD ADAPTOR IS MISSING LOCKING BEARINGS. 75MM, 85MM, AND CAP DO NOT SCREW TOGETHER PROPERLY, NEED NEW PRODUCTS FOUND DEFECTIVE DURING TRAINING IN OFFICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9619782 ↗
• MalfunctionMay 30, 2019Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THERE IS A COMBINATION OF FOUR INSTRUMENTS THAT WERE DAMAGED DURING THIS CASE. IT WAS DISCOVERED THAT THESE ITEMS WERE DAMAGED WHILE PUTTING THEM BACK TOGETHER IN STERILE PROCESSING FOLLOWING THE CASE. THERE WERE NO DELAYS DURING THE ACTUAL CASE. THE FIRST TWO INSTRUMENTS THAT WERE DAMAGED "OR" THE DISASSEMBLY A TOOL THREADED CAP, AND THE DISASSEMBLE A TORQUE SHAFT 75 MM. THERE IS A THREAD ON THE THREADED CAP THAT IS STRIPPED AND THE 75 MM TORQUE SHAFT CANNOT BE REMOVED FROM THE THREADED CAP. THE SECOND SET OF INSTRUMENTS THAT WERE DAMAGED THAT WORK TOGETHER OR THE BOLT TORQUE WRENCH HANDLE IN THE BOLT TORQUE WRENCH BODY. THE T HANDLE THAT ATTACHES TO THE BOLT TORQUE WRENCH HANDLE BROKE OFF OF THAT DEVICE AND CANNOT BE FOUND IN STERILE PROCESSING. HOWEVER, THERE IS STILL A PORTION OF THE BOLT TORQUE WRENCH HANDLE THAT IS ATTACHED TO THE BOLT TORQUE WRENCH BODY AND CANNOT BE REMOVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655299 ↗
• MalfunctionOct 1, 2018Break; Break

  IT WAS REPORTED THAT THE 75MM TORQUE SHAFT WAS SENT TO HOSPITAL WITH A PART BROKEN OFF IN IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7921807 ↗