RECLAIM 2975-31-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295156352), received between Mar 22, 2018 and Jan 14, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NECK TRIAL AND THE PROXIMAL BODIES WERE STRIPPED DURING NORMAL USE. THE T-HANDLE HEX SCREW DRIVER WAS TORQUED- LIMITING IN REVERSE AS WELL. A REPLACEMENT FOR THESE 4 ITEMS IS NEED TO THE KNOXVILLE OFFICE. NO SURGICAL DELAY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11171477 ↗
• MalfunctionDec 18, 2020Break; Break

  IT WAS REPORTED THAT THE HEX DRIVER WAS BROKEN DURING NORMAL USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11038856 ↗
• MalfunctionDec 17, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE RECLAIM SCREW DRIVER IS STRIPPED AND NO LONGER WORKING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11029111 ↗
• MalfunctionAug 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HANDLE HOUSING FELL OFF. ALL PIECES RECOVERED FROM PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10437325 ↗
• MalfunctionAug 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE T HANDLE HOUSING FELL OFF. ALL PIECES RECOVERED FROM PATIENT. SURGICAL DELAY WAS NOTED.

  Patient problems: No Code Available

  MAUDE report 10437222 ↗
• MalfunctionAug 5, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED AS CHECKED THE RECLAIM INSTRUMENT SET PRIOR TO SURGERY AND THE NECK TRIAL WAS STUCK IN A LOCKED POSITION. HE COULD NOT LOOSEN THE TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10366955 ↗
• MalfunctionJun 6, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREW DRIVER WAS STRIPPED. NECK X2 SCREW WAS STUCK. OTHER INSTRUMENTS NOT ENGAGING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8676076 ↗
• MalfunctionDec 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE UNIVERSAL HEX DRIVER IS STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185113 ↗
• MalfunctionJul 23, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE RECLAIM UNIVERSAL HEX DRIVER IS WORN. THE HANDLE IS STRIPPED. FOUND IN OFFICE SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7709768 ↗
• MalfunctionApr 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ALSO THE T-HANDLE/SCREW DRIVER KEPT SLIPPING AND WOULD NOT SNAP AT THE APPROPRIATE TORQUE, IT WOULD JUST KEEP SPINNING. SURGICAL DELAY OF 5 MINUTES AND ALL PIECES WERE RETRIEVED.

  Patient problems: Not Applicable

  MAUDE report 7425068 ↗
• MalfunctionMar 22, 2018Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn

  IT WAS REPORTED FOR UNKNOWN REASON. THE OFFICE SET AND DID NOT EFFECT SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7361385 ↗