SMR System 1374.15.310Recalls & reported problems
Limacorporate SPA · SMR System - Connector+Screw Small Standard · Class 2 · Implant
All models of SMR System (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390271561), received between Dec 2, 2025 and Dec 2, 2025 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K110598); they may or may not involve this specific model.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Medical device site infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO INFECTION. THE FOLLOWING DEVICES WERE IMPLANTED IN THE PREVIOUS SURGERY, PERFORMED ON (B)(6) 2025: · SMR REVERSE HP GLENOSPHERE 44 MM (PRODUCT CODE 1374.50.440, LOT #2512625 - STER. 2500090) · SMR REVERSE HP LINER SHORT (PRODUCT CODE 1362.09.010, LOT #2510318 - STER. 2500108) · BONE SCREW Ø6.5 H.35MM (PRODUCT CODE 8420.15.040, LOT #2414295 - STER. 2400126). SOLD IN US. · BONE SCREW Ø6.5 H.35MM (PRODUCT CODE 8420.15.040, LOT #2419835 - STER. 2400171). SOLD IN US. · SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #2510276 - STER. 2500099) · SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #2504866 - STER. 2500071). SOLD IN US. · SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2508622 - STER. 2500087). SOLD IN US. · SMR CEMENTED REVISION STEM Ø15 MM (PRODUCT CODE 1309.15.156, LOT #1921189 - STER. 2500108). SOLD IN US. ONLY THE SMR REVERSE HP GLENOSPHERE 44 MM AND SMR REVERSE HP LINER SHORT WERE EXPLANTED AND REPLACED DURING THE REVISION SURGERY. PATIENT IS MALE, 73 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.
Patient problems: Medical device site infection
MAUDE report 23692505 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K110598. One submission often covers many models, so check the product and lot details in each record.
- Z-1711-2016 · Apr 8, 2016 · TerminatedSMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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