RECLAIM 2975-00-605Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295155959), received between Aug 7, 2017 and Aug 5, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: NOT SURE IF THIS WAS EVER PROCESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905421 ↗
• MalfunctionFeb 23, 2024Break; Break

  THIS PATIENT HAD A LEFT TOTAL HIP. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS NOTICED AN ASSEMBLY TOOL WITH THE RECLAIM INSTRUMENTS HAD A DAMAGED LOCKING SPRING. ALL PIECES WERE PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18771921 ↗
• MalfunctionJan 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER DECONTAMINATION IT WAS FOUND THAT SPRING WAS REMOVED FROM ASSEMBLY ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466107 ↗
• MalfunctionApr 26, 2021Material Deformation; Unintended Movement; Material Deformation; Unintended Movement

  IT WAS REPORTED THAT THE SPRING DEFORMED, COMING LOOSE FROM GROOVE. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725046 ↗
• MalfunctionMar 12, 2021Material Twisted/Bent; Unintended Movement; Material Twisted/Bent; Unintended Movement

  IT WAS REPORTED THAT THE RECLAIM 75 ADAPTER ASSEMBLY TOOL WAS STRIPPED. IT FIT TOO LOOSELY ON ASSEMBLY. NO PIECES BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477730 ↗
• MalfunctionFeb 3, 2021Use of Device Problem; Illegible Information; Use of Device Problem; Illegible Information

  SPRING INSIDE THE ATTACHMENT IS NO LONGER THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274130 ↗
• MalfunctionSep 28, 2020Break; Mechanical Jam; Break; Mechanical Jam

  A) WHAT PART OF THE INSTRUMENT BROKE? THE PART OF THE OFFSET REAMER THAT FITS INSIDE OF THE CASING WAS STUCK AND WOULD NOT COME APART, NOR SLIDE ALL THE WAY IN SO THAT IT COULD SEAT AND BE PLACED IN A DRILL. B) DID IT BREAK INTO TWO OR MORE PIECES? NO, IT DID NOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593914 ↗
• MalfunctionJul 2, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE 75 MM PROXIMAL BODY ADAPTER FOR THE RECLAIM ASSEMBLY TOOL IS MISSING AN O-RING. WE NEED A REPLACEMENT SENT TO US. WE WERE STILL ABLE TO USE THE 75 MM ADAPTER WITH NO ISSUES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224305 ↗
• MalfunctionNov 5, 2019Material Deformation; Material Deformation

  BAL SEAL HAS BEEN DAMAGED. DAMAGED BAL SEALS ARE BEING RETURNED. THE ASSEMBLY TOOL BODY IS NOT BEING RETURNED, AS THE BAL SEALS HAVE BEEN REPLACED. THEY HAVE BEEN REPLACED WITH BAL SEALS X574850 AS PER DRAWING ATTACHED TO THIS PRODUCT COMPLAINT FORM. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279373 ↗
• MalfunctionJun 6, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; 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 8676079 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN IN SET. SPRING IS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210842 ↗
• MalfunctionNov 28, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND DAMAGED IN STERILE PROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111348 ↗
• MalfunctionOct 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LOCKING SPRING IS LOOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7924031 ↗
• MalfunctionSep 28, 2018Break; Break

  IT WAS REPORTED THAT THE SPRING FELL OUT OF PIECE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919088 ↗
• MalfunctionJun 20, 2018Component Missing; Defective Device; Component Missing; Defective Device

  RECLAIM INSTRUMENT'S SPRING UNLODGED DURING CLEANING AND SO REQUIRES REPLACEMENT. PINNACLE SCREW DRIVER'S BLACK MATERIAL IS DEGRADING AND SO REQUIRES REPLACEMENT. PINNACLE DRILL BIT IS NO LONGER SHARP AND REQUIRES REPLACEMENT. PLEASE SHIP ALL 3 ON (B)(6). PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7620913 ↗
• MalfunctionApr 27, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT WHILE PUTTING AWAY THE RECLAIM SET SALES REP NOTICED THE SPRINGS WERE MISSING FROM TWO INSTRUMENTS. NEED TO HAVE THESE INSTRUMENT REPLACED FOR A THURSDAY CASE. THE INSTRUMENT WILL BE RETURNED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7467941 ↗
• MalfunctionOct 25, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE RETENTION SPRING CAME OUT. / / INVESTIGATION METHOD: / / INVESTIGATION SUMMARY:

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6976927 ↗
• MalfunctionOct 18, 2017Break; Break

  IT WAS REPORTED THAT THE COIL SPRINGS ARE MISSING FROM THE INSIDE OF BOTH THE ASSEMBLY TOOL ADAPTORS. INSTRUMENTS WERE NOT USED IN SURGERY.

  Patient problems: No Information

  MAUDE report 6958171 ↗
• MalfunctionAug 7, 2017Break; Break

  IT WAS REPORTED THAT UPON INSPECTING THE INSTRUMENTS PRIOR TO A CASE THAT WAS CANCELLED, IT WAS FOUND OUT THAT THE SERING ON THIS INSTRUMENT WAS DAMAGED AFTER YEARS IN USE.

  Patient problems: No Information

  MAUDE report 6771323 ↗