SMR System 1350.15.020Recalls & reported problems
Limacorporate SPA · SMR System - Humeral Body Trauma Long · Class 2 · Implant
- 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 08033390272490), received between Jan 2, 2026 and Jan 2, 2026 — classified as 1 injury.
2 other recalls cover devices cleared under the same FDA submission (K100858); 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. How this data works · Data updated Oct 13, 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.
InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
PATIENT UNDERWENT SURGERY FOR IRRIGATION AND DEBRIDEMENT OF SHOULDER TISSUE FOR INFECTION ON OCTOBER 24TH 2025, 14 DAYS AFTER A REVISION SURGERY IN WHICH FOLLOWING SHOULDER PROSTHETIC COMPONENTS WERE IMPLANTED: SMR HUMERAL BODY TRAUMA LONG (PN 1350.15.020, LOT 1906991, STERILIZATION (B)(6), ADAPTOR TAPER ECCENTRICAL 2MM LONG (PN 1331.15.272, LOT 2509346, STERILIZATION (B)(4)) CTA HEAD DIA 50MM NICKEL-FREE (PN 1323.15.500, LOT 2003709, STERILIZATION (B)(4)) - COMPASSIONATE CARE FDA APPROVED, OTHER MANUFACTURER GLENOID COMPONENT (ARTHREX). DURING CURRENT SURGERY FOR INFECTION ONLY IRRIGATION AND DEBRIDEMENT WERE PERFORMED, WITH NO IMPLANT REPLACEMENT SINCE NO INDICATION OF PROBLEMS WITH THE PROSTHESIS WERE FOUND. PATIENT IS A FEMALE, DATE (B)(6) 1954. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Medical device site infection
MAUDE report 23942960 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K100858. One submission often covers many models, so check the product and lot details in each record.
- Z-2540-2015 · Aug 14, 2015 · TerminatedSMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
- Z-2539-2015 · Aug 14, 2015 · TerminatedSMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.