SMR Shoulder SMALL-R Baseplate ExtractorRecalls & reported problems
Limacorporate SPA · SMALL-R Baseplate Extractor · Class 2
All models of SMR Shoulder (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390094856), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Mechanical Problem
DURING A SHOULDER PROSTHESIS REVISION PERFORMED ON (B)(6) 2026, AN INTRA-OPERATIVE ISSUE RELATED TO THE INSTRUMENTATION WAS ENCOUNTERED. THE SURGEON EXPERIENCED DIFFICULTIES USING TWO BASEPLATE EXTRACTOR SMALL-R DEVICES (PRODUCT CODE 9013.75.391; LOT 21BH07Z AND LOT 23BH03A) TO REMOVE THE BASEPLATE FROM THE TT PEG. SPECIFICALLY, THE SPLINES OF THE EXTRACTORS BENT DURING THE EXTRACTION ATTEMPTS, MAKING IT IMPOSSIBLE TO DISENGAGE THE BASEPLATE FROM THE PEG. IN ADDITION, THE SMALL-R CANNULATED REAMER (PRODUCT CODE 9013.75.395; LOT 15AQ00R), INTENDED FOR TT PEG REMOVAL, WAS DIFFICULT TO USE, PARTLY DUE TO THE ABSENCE OF AN APPROPRIATE LEVERAGE HANDLE. AS A RESULT OF THESE DIFFICULTIES, AN ALTERNATIVE INSTRUMENT (BRISTOW) WAS USED; HOWEVER, DESPITE MULTIPLE ATTEMPTS, THE PEG COULD NOT BE REMOVED. THE SURGEON SUBSEQUENTLY MODIFIED THE SURGICAL PLAN: THE ORIGINAL PEG WAS LEFT IN SITU, AND A NEW BASEPLATE WITH NEW SCREWS WAS IMPLANTED ONTO THE EXISTING PEG. THE SIZE OF THE GLENOSPHERE WAS ALSO REDUCED COMPARED TO THE INITIAL PLAN. THE OVERALL PROCEDURE TIME WAS PROLONGED BY APPROXIMATELY 45 MINUTES. THE EVENT OCCURRED IN AUSTRALIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377809 ↗
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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