RECLAIM 2975-00-620Recalls & reported problems
Depuy (Ireland) · RECLAIM ASSEMBLY TOOL ADAPTOR 105mm · Class 1
All models of RECLAIM (149)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295155980), received between Apr 27, 2018 and Jan 23, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- Break1
- Component Missing1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Material Deformation
IT WAS REPORTED THAT DURING HIP SURGERY, THE RECLAIM MODULAR INSTRUMENTS WERE STRIPPED OUT AND NON-FUNCTIONAL. DR. HAD TO TRIAL OFF REAL IMPLANTS. NO HARM TO PATIENT, 90 MIN SURGERY DELAY DUE TO INABILITY TO APPROPRIATELY TRIAL AND STRUGGLE WITH INSTRUMENTS. ACTIVITY LEVEL - YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24172893 ↗MalfunctionJul 26, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TORQUE WRENCH BODY AND T-HANDLE CONNECTION WERE STRIPPED. ASSEMBLY TOOL ADAPTERS ARE NOT BEING RETAINED ON THE HOUSING. REAMER EXTRACTOR ADAPTER IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17398357 ↗MalfunctionDec 2, 2021Break; Break
AS SPD WAS PROCESSING IT, ONE OF THE STAFF NOTICED THAT ON THE 105MM ADAPTOR THERE IS A SPRING MISSING THAT GOES ALL AROUND THE INSIDE OF THE ADAPTOR TOOL ASSEMBLY AROUND THE CHANNEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12917443 ↗MalfunctionFeb 18, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT THREADS ON PULL ROD ARE STRIPPED. NOTICED IN SPD SO WASN¿T T USED ON A CASE YET. 85 AND 105 ADAPTERS HAVE THE LOCKING SPRINGS AND THEY ARE BENT AND DAMAGED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11343226 ↗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 7467974 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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