SMR Shoulder Humeral Head (REF 1322.09.480)Recalls & reported problems
Limacorporate SPA · Humeral heads (CoCrMo) dia.48mm · Class 2 · Implant
All models of SMR Shoulder (67)
Data updated Oct 18, 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 08033390001403), received between Jan 22, 2026 and Jan 22, 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. 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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain1
- Muscle/Tendon Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY PERFORMED ON (B)(6) 2025. PATIENT PRESENTED SEVERAL YEARS POST-OP WITH COMPLAINTS OF PAIN. SURGEON CONVERTED THE PROSTHETIC ASSEMBLY FROM AN ANATOMIC CONFIGURATION TO A REVERSE DUE TO NO LONGER INTACT ROTATOR CUFF. SURGEON REMOVED THE PRE-EXISTING HUMERAL HEAD (PART NUMBER 1322.09.480), NEUTRAL ADAPTOR TAPED (1330.15.270), FINNED HUMERAL BODY (PART NUMBER 1350.15.110) AND POLYETHYLENE LINER FOR METAL BACK (PART NUMBER 1377.50.005), AND IMPLANTED THE REVERSE CONFIGURATION CONSISTING OF A 36MM ECCENTRICAL GLENOSPHERE (PART NUMBER 1376.09.031) WITH LATERALIZED CONNECTOR (PART NUMBER 1374.15.314), A REVERSE 140° HUMERAL BODY (PART NUMBER 1352.15.011) AND REVERSE LINER +3MM (PART NUMBER 1360.50.815). SURGERY WAS COMPLETED AS INTENDED. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS LOT NUMBER OF INVOLVED COMPONENTS. PATIENT IS MALE, DATE OF BIRTH FEBRUARY 22ND, 1950. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Implant Pain; Muscle/Tendon Damage
MAUDE report 24144121 ↗
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 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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