RECLAIM 2975-00-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295156062), received between Sep 22, 2017 and May 19, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECLAIM DISASSEMBLY BODY DEVICE AND THE DISASSEMBLY BODY COLLET DEVICE WERE FOUND STUCK TOGETHER AND WOULD NOT SEPARATE. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT OR USER HARM AND NO DELAYS IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222661 ↗
• MalfunctionMay 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENTS BROKE DURING EXPLANT. THE PROXIMAL BODY OF RECLAIM WAS COLD WELDED ONTO THE DISTAL STEM. THE DISTAL STEM DID NOT COME OUT. PATIENT WAS NOT HARMED. NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148565 ↗
• MalfunctionFeb 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE THE SURGEON ATTEMPTED TO DISSASSEMBLE THE PROXIMAL BODY FROM THE DISTAL STEM. THE LOCKING PIECE OF THE BODY COULD NOT ENGAGE AND EXPAND THE COLLET WHILE IT WAS IN THE PROXIMAL BODY. THIS PREVENTED THE COLLET FROM LOCKING INTO THE PROXIMAL BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414968 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT THE TOOL BROKE ON THE DISTAL PORTION.

  Patient problems: Insufficient Information

  MAUDE report 21251340 ↗
• MalfunctionJan 22, 2025Break; Break

  IT WAS REPORTED THAT TOOL BROKE ON DISTAL PORTION.

  Patient problems: Insufficient Information

  MAUDE report 21207376 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TAPER OF STEM BROKE. DISASSEMBLY JIG COLD THREADED-UNABLE TO UNSCREW. NO PARTS LEFT BEHIND. NO LOOSENING, ALL PIECES RETRIEVED FROM PATIENT. NO DELAY. NO OTHER INFORMATION KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20522319 ↗
• MalfunctionMay 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EXTRACTION COLLET WOULD NOT ROTATE TO LOCK IN PLACE ON THE PROXIMAL BODY OF RECLAIM IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004306 ↗
• MalfunctionMay 25, 2023Structural Problem; Device-Device Incompatibility; Structural Problem; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED. A. PLEASE VERIFY, IF THE INSTRUMENT WAS USED, DURING SURGERY? IF YES, WAS THERE ANY SURGICAL DELAY? WHAT WAS THE DURATION OF THE DELAY? YES, 5 MIN. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT, BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002907 ↗
• MalfunctionMar 22, 2023Naturally Worn; Naturally Worn

  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 16590363 ↗
• MalfunctionJun 27, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  RECLAIM DISASSEMBLY TOOL WAS DAMAGED DURING PROXIMAL BODY EXTRACTION. THE TEETH WERE SHEERED OFF AND THREE PIECES ARE NOW STUCK TOGETHER. WE WERE UNABLE TO REMOVE PROXIMAL. ALL BROKEN PIECES WERE RETRIEVED AS FAR AS WE COULD TELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828301 ↗
• MalfunctionJan 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  INSTRUMENTS WOULD NOT COME APART AFTER SURGERY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193556 ↗
• 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 12699374 ↗
• MalfunctionSep 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER REMOVING THE LOCKING BOLT, THE DISASSEMBLY BODY WOULD NOT DISENGAGE FROM THE PROXIMAL BODY IN SITU. THIS FORCED THE SURGEON TO TAKE NECESSARY STEPS TO REMOVE THE INSTRUMENT FROM THE PATIENT. BECAUSE OF THIS, WE WERE NOT ABLE TO COMPLETE THE SURGICAL PLAN OF REMOVING THE IMPLANT. SURGICAL DELAY OF 15 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12505844 ↗
• MalfunctionAug 30, 2021Break; Break

  IT WAS REPORTED THAT THE TEETH OF THE INSTRUMENT BROKE OFF WHEN TRYING TO REMOVE A RECLAIM HIP STEM. THERE WAS 2 PLUS HOURS SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 12386132 ↗
• 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 11887042 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT THE HEAD WAS REVISED FOR INFECTION. ATTEMPTS WERE MADE TO REVISE RECLAIM PROXIMAL BUT THE DISASSEMBLY TOOL BROKE IN DIFFERENT PIACES. NO PIECES WERE LEFT IN THE PATIENT. SURGERY TIME WAS EXTENDED FOR 1 HR. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11813780 ↗
• MalfunctionAug 14, 2020Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS BROKE WHILE TRYING TO DISENGAGE PROXIMAL BODY. THERE WAS 1 HOUR OF SURGICAL DELAY.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10410740 ↗
• MalfunctionDec 4, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE SCRUB TECH WAS TRYING TO GRIP THE IMPLANT WITH THE DISASSEMBLY TOOL AND THE TOOL WAS NOT GRIPPING (HOLDING ONTO) THE IMPLANT CORRECTLY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 10. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9411848 ↗
• MalfunctionOct 29, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THE SURGEON WAS AFTER CHANGING THE PROXIMAL BODY VERSION AFTER HE HAD ENGAGED THE TAPER, THIS WAS NOT POSSIBLE THE REQUIRED INSTRUMENT WAS CROSS-THREADING AND COULD NOT BE USED TO LOCK INTO THE PROXIMAL BODY. SURGEON WAS SATISFIED WITH THE OUTCOME. NO DELAY IN THE SURGERY, NO AE REPORTED. PRODUCT DESCRIPTION: RECLAIM DISASSEMBLY INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252473 ↗
• MalfunctionOct 8, 2018Material Twisted/Bent; Material Twisted/Bent

  THE OFFICE SET RECLAIM DISASSEMBLY BODY WAS REPORTED WITH UNKNOWN REASON. IT DID NOT AFFECT SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7942399 ↗
• 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 DECEMBER 6TH 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 7859380 ↗
• MalfunctionMay 29, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DISASSEMBLY TOOL BODY AND DISASSEMBLY TOOL ROD APPEAR TO HAVE COLD WELDED TOGETHER AND WILL NOT COME APART. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7549649 ↗
• MalfunctionDec 22, 2017Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS USING THE INSTRUMENT TO DISENGAGE THE PROXIMAL BODY FROM THE DISTAL STEM. THE TABS THAT ARE SUPPOSED TO ENGAGE THE DISTAL STEM BROKE OFF. ALL PIECES WERE RETRIEVED AND VERIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7141655 ↗
• MalfunctionDec 13, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED HIP AND WAS BROUGHT TO OR FOR OPEN REDUCTION. STEM SEEMED TO NOT HAVE ENOUGH ANTIVERSION WHEN RELOCATED AND CHECKED FOR STABILITY. HEAD WAS REMOVED, LINER REMOVED, SET SCREW REMOVED AND PROXIMAL BODY DISASSOCIATED BY PROVIDED INSTRUMENTATION. TRIAL REDUCTION REPEATED AND STABILITY WAS SIGNIFICANTLY IMPROVED WITH MORE VERSION. PROXIMAL BOD REIMPLANTED ALONG WITH NEW LINER AND HEAD. AFTER CASE, THE REMOVAL DEVICE WAS BADLY TO BE SEPARATED ALTHOUGH IT FUNCTIONED AS EXPECTED INTRAOPERATIVELY. IT WILL BE RETURNED. NO INSTRUMENTS WERE BROKEN OPERATIVELY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7112496 ↗
• MalfunctionOct 20, 2017Bent; Bent

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS FOUND IN THE SET BENT. IT WAS ALSO REPORTED THAT THE INSTRUMENT WAS NOT USED.

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

  MAUDE report 6965090 ↗