RECLAIM 2975-00-900Recalls & reported problems
Depuy (Ireland) · RECLAIM DISTAL STEM SLAP ADAPTOR · 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 10603295156178), received between Jan 5, 2018 and Jan 23, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Material Twisted/Bent2
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT WAS CROSS THREADED INTO ASSEMBLY HOUSING AND THREADS ARE DAMAGED THAT GO INTO DISTAL STEM. SURGEON BECAME ANGRY AND THREW AWAY THE TWO DAMAGED PIECES. THEY WILL NOT BE RETURNED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16223366 ↗MalfunctionSep 25, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE THREADS WERE STRIPPED. IT WAS NOTICED IN THE OFFICE AND NOT DURING A CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10589805 ↗MalfunctionMar 19, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE THREAD IS DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9856501 ↗MalfunctionAug 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE ASSEMBLY POLL ROD AND STEM SLAP ADAPTOR THREADS WERE CROSS THREADED WHILE DOING THE ASSEMBLY OF THE RECLAIM STEM. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7822419 ↗MalfunctionJan 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THERE IS A REMOVAL OF RECLAIM HIP STEM. INSTRUMENTS WERE CROSS THREADED IN STEM IMPLANT. NEEDS REPLACING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7167156 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- 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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