PROSTALAC 2541-44-000Recalls & reported problems
Depuy Orthopaedics, Inc. · PROSTALAC MOLD HANDLE · Class 1
All models of PROSTALAC (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295129561), received between Sep 13, 2017 and Apr 2, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Connection Problem1
- Material Deformation1
- Mechanical Jam1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Break; Scratched Material
IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT REFUSES TO RESTERILIZE THE INSTRUMENTS ANY LONGER DUE THE WEAR AND TEAR OF THE METAL. MANY CHIPS AND SCRATCHES ON THEM COMPROMISING PATIENT SAFETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767396 ↗MalfunctionJul 29, 2020Mechanical Jam; Mechanical Jam
DURING CASE PREPARATION, THE MOLD HANDLE GOT STUCK INTO THE MOLD BASE. WE USED VICE GRIPS DURING THE CASE. NO ADVERSE EFFECTS TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10339430 ↗MalfunctionSep 13, 2017Connection Problem; Material Deformation; Connection Problem; Material Deformation
IT WAS REPORTED THAT THE PROSTALAC MOLD HANDLE AND PROSTALAC MOLD BASE WAS DAMAGED.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 6862115 ↗
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- 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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